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Trial record 9 of 62 for:    Excel Diagnostics

Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00572728
Recruitment Status : Completed
First Posted : December 13, 2007
Results First Posted : January 20, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions Procedure: CT
Drug: 18F-FLT
Procedure: PET
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 90 [1]
Eligible 87
Enrolled Under Amendment 5 or Later 82
Did Not Withdraw 72
On Study 71
Completed FLT1 Scan 67
First Therapy Initiated 65
Completed FLT2 Scan 60
Second Chemotherapy Initiated 59
Second Chemotherapy Initiated After FLT2 52
Pathology Complete 51
Completed FLT3 Scan 43 [2]
LN Evaluation After NAC 38 [3]
RCB Evaluation 35 [4]
Completed 51 [5]
Not Completed 39
Reason Not Completed
Withdrawal by Subject             10
Ineligible             3
Enrolled under Amendment 4             5
Offstudy due to complicating disease             1
FLT1 not completed             4
First Chemotherapy not initiated             2
FLT2 not completed             5
Second chemotherapy not initiated             1
FLT2 after second chemotherapy initiated             7
Pathology missing             1
[1]
Registered
[2]
Secondary analysis milestone: 43 pts had FLT-3 performed.
[3]
Secondary:38 patients were available for histopathological LN evaluation after NAC
[4]
Secondary: histopathology was available in 35 patients for RCB evaluation
[5]
51 patients eligible for primary objective analysis
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 90
Hide Baseline Analysis Population Description
Registered
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 90 participants
51
(22 to 83)
Gender   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
90
 100.0%
Male
0
   0.0%
[1]
Measure Description: Overall Number of Baseline Participants
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Hispanic or Latino
9
  10.0%
Not Hispanic or Latino
75
  83.3%
Unknown or Not Reported
6
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
American Indian or Alaska Native
1
   1.1%
Asian
2
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
25
  27.8%
White
51
  56.7%
More than one race
0
   0.0%
Unknown or Not Reported
11
  12.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 90 participants
90
1.Primary Outcome
Title %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response
Hide Description The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies
Time Frame Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)
Hide Outcome Measure Data
Hide Analysis Population Description
Percent Change in Maximum Standardized FLT uptake between the baseline (pre-therapy, FTL-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2)
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: percentage change of SUVmax
38.78  (26.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments

A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL):

H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC >= 0.75 AUC = ROC(%ΔSUVmax| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 –SUVmax at FLT2)/SUVmax at FLT1 x 100

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments The Delong method was used to test if the observed AUC was significantly different than 0.5 with the one‐sided p value DeLong ER, DeLong DM, Clarke‐Pearson DL, Biometrics (1988)
Method Delong method
Comments one‐sided p-value
Method of Estimation Estimation Parameter AUC
Estimated Value 0.68
Confidence Interval (1-Sided) 95%
.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments

percent change in SUVmax was computed as: %ΔSUVmax = 100*(FLT1‐FLT2)/FLT1 a 90% 2-sided confidence interval was constructed from 2000 Bootstrapping estimates from which the 1-sided 95% CI was derived.

Hanley SE(AUC) reported.

2.Secondary Outcome
Title Correlation Between SUVmax and Ki‐67 LI at FLT1(Baseline PET)
Hide Description

For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 .

Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells.

Time Frame Baseline (FLT-1)
Hide Outcome Measure Data
Hide Analysis Population Description
1 of the 73 participants did not have both FLT-1 and Ki-67 LI available data
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 72
Mean (Standard Deviation)
Unit of Measure: Standard Uptake Values (SUVmax)
5.71  (3.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-1 and Ki-67 LI a Fisher's z Transformation was applied to adjust for bias in the Spearman Correlation Statistic
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method spearman correlation method
Comments [Not Specified]
Method of Estimation Estimation Parameter spearman correlation
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0.13 to 0.54
Estimation Comments This estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic
3.Secondary Outcome
Title Correlation Between SUVmax and Ki‐67 LI at FLT3 (Post-NAC)
Hide Description For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells.
Time Frame Post-NAC (FLT3)
Hide Outcome Measure Data
Hide Analysis Population Description
43 patients who had suitable post‐NAC tissue samples for correlation between surgical specimens and FLT3 SUVs
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post-NAC (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: Standard Uptake Values (SUVmax)
1.88  (1.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-3 and Ki-67 LI
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Spearman Correlation method
Comments we use Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic
Method of Estimation Estimation Parameter Spearman Correlation
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.47 to 0.81
Estimation Comments this estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic
4.Secondary Outcome
Title SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
Hide Description

While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein.

Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III

Time Frame Baseline (FLT-1)
Hide Outcome Measure Data
Hide Analysis Population Description
@ Baseline: 35 patients with FLT-1 were evaluable for RCB: 14 patients with RCB 0/I and 21 patients with RCB II/III
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Standard Uptake Values (SUVmax)
All Data 5.9  (3.2)
RCB 0,I 6.2  (2.9)
RCB II,III 5.8  (3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments

H0: Mean SUVmax (RCB 0,I) = Mean SUVmax (RCB II,III) After dichotomization, Wilcoxon two-sample test was used to compare uptake values between RCB groups.

In other words, we are comparing the means (of SUVmax) @ FLT1 between the RCB 0,I and the RCB II,III groups..

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments two‐sided exact p value from Wilcoxon two‐sample test
5.Secondary Outcome
Title SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
Hide Description

While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein.

Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III

Time Frame early treatment (FLT2)
Hide Outcome Measure Data
Hide Analysis Population Description
after one cycle of NAC (FLT2): 35 patients had FLT-2 and RCB evaluation: 14 patients with RCB 0/I and 21 patients with RCB II/III
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Standard Uptake Values (SUVmax)
All Data 3.3  (2.0)
RCB 0,I 3.5  (2.3)
RCB II,III 3.2  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT2 between the RCB 0,I and the RCB II,III groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments *two‐sided exact p value from Wilcoxon two‐sample test
6.Secondary Outcome
Title SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
Hide Description The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein.
Time Frame post-NAC (FLT-3)
Hide Outcome Measure Data
Hide Analysis Population Description
After completion of NAC (FLT-3): only 31 patients had both FLT3 and RCB evaluation: 11 patients with RCB 0/I and 20 patients with RCB II/III
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: Standard Uptake Values (SUVmax)
All Data (FLT3) 1.8  (1.8)
RCB 0/I (FLT3) 0.7  (0.3)
RCB II/III (FLT3) 2.4  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT3 between the RCB 0,I and the RCB II,III groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments two‐sided exact p value from Wilcoxon two‐sample test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments H0: %SUVmax FLT1‐FLT3 (RCB 0,I) = %SUVmax FLT1‐FLT3 (RCB II,III) A logistic regression model is used to determine if a larger percent change in SUVmax is associated with (RCB 0,I); the null hypothesis assumes that there is no association.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.76 to 0.97
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor
Hide Description

To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome.

Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section

Time Frame Baseline (FLT-1) and post-NAC (FLT-3)
Hide Outcome Measure Data
Hide Analysis Population Description
43 patients who had both FLT1 and FLT3 scans
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

CT: Undergo 18F-FLT PET/CT

18F-FLT: Undergo 18F-FLT PET/CT

PET: Undergo 18F-FLT PET/CT

Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percentage change in SUVmax
All Data 38.8  (26.1)
pCR 52.7  (22.8)
no-pCR 35.8  (26.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments

ROC analysis was used to compute the AUC and evaluate if %ΔSUVmax FLT1‐FLT3 is predictive of pCR with alpha=0.05.

The Null Hypothesis assumes that the P(%ΔSUVmax FLT1‐FLT3|pCR)= 1 - P(%ΔSUVmax FLT1‐FLT3|non-pCR) that is: H0: AUC =0.5 (guessing)

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Delong 1-sided p-value (alpha=0.05)
Method Delong Method
Comments The Delong-Delong Clark-Pearson method using modified U-statistics was used to evaluate the AUC
Method of Estimation Estimation Parameter AUC
Estimated Value 0.83
Confidence Interval (2-Sided) 90%
.72 to .94
Estimation Comments [Not Specified]
8.Secondary Outcome
Title %Change SUVmax From FLT1‐FLT2 to Predict Lymph Node Status at Surgery
Hide Description Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome.
Time Frame Baseline (FLT-1) and Early Therapy (FLT-2)
Hide Outcome Measure Data
Hide Analysis Population Description
Data on 38 patients having FLT1 and FLT2 were available for histopathological LN evaluation after NAC: 14 with negative nodes, 15 with 1‐3 LN metastases and 9 with >3 LN metastases
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: percent change in SUVmax from FLT1‐FLT2
All Data 44.9  (26.0)
0 Positive Nodes 47.7  (29.0)
1-3 Positive Nodes 43.8  (23.8)
3+ Positive Nodes 42.6  (27.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments

Kruskal‐Wallis one‐way ANOVA was used to test whether there was a difference in %SUVmax (FLT1-FLT2) among LN statuses.

H0: no difference between the 3 LN status.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Kruskal-Wallis
Comments two‐sided p value from Kruskal‐Wallis one‐way ANOVA
9.Secondary Outcome
Title %Change SUVmax From FLT1‐FLT3 to Predict Lymph Node Status at Surgery
Hide Description %change in SUVmax from FLT1‐FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1‐FLT3 will be consider the outcome.
Time Frame Baseline (FLT-1) and post-NAC (FLT-3)
Hide Outcome Measure Data
Hide Analysis Population Description
Data on 30 patients with FLT3 were available for histopathological LN evaluation after NAC: 11 with negative nodes, 13 with 1‐3 LN metastases and 6 with >3 LN metastases
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: percent change in SUVmax from FLT1‐FLT3
All Data 71.4  (29.1)
0 Positive Nodes 65.2  (42.2)
1-3 Positive Nodes 77.6  (18.1)
3+ Positive Nodes 69.5  (19.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diagnostic (18F-FLT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments two‐sided p value from Kruskal‐Wallis one‐way ANOVA
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic (18F-FLT)
Hide Arm/Group Description

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Diagnostic (18F-FLT)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Diagnostic (18F-FLT)
Affected / at Risk (%) # Events
Total   0/90 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnostic (18F-FLT)
Affected / at Risk (%) # Events
Total   8/90 (8.89%)    
Gastrointestinal disorders   
Gastrointestinal pain   1/90 (1.11%)  1
Nausea   1/90 (1.11%)  1
Diarrhea   1/90 (1.11%)  1
Mucositis oral   1/90 (1.11%)  1
General disorders   
Flushing   2/90 (2.22%)  3
Paresthesia   2/90 (2.22%)  2
Peripheral sensory neopathy   2/90 (2.22%)  2
Fever   1/90 (1.11%)  1
Wound Infenction   1/90 (1.11%)  1
Nail discoloration   1/90 (1.11%)  1
Pain in extremity   1/90 (1.11%)  1
Allergic rhinitis   1/90 (1.11%)  1
Infections and infestations   
Generalized muscle weakness   1/90 (1.11%)  1
Psychiatric disorders   
Fatigue   1/90 (1.11%)  1
Respiratory, thoracic and mediastinal disorders   
Insomnia   1/90 (1.11%)  1
Upper respiratory infection   1/90 (1.11%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ben Herman
Organization: ACRIN
Phone: 401.863.9188
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00572728     History of Changes
Obsolete Identifiers: NCT00566293
Other Study ID Numbers: NCI-2009-00266
NCI-2009-00266 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACRIN 6688 ( Other Identifier: American College of Radiology Imaging Network )
8029 ( Other Identifier: CTEP )
N01CM27165 ( Other Identifier: US NIH Grant/Contract Award Number )
First Submitted: December 11, 2007
First Posted: December 13, 2007
Results First Submitted: March 18, 2015
Results First Posted: January 20, 2016
Last Update Posted: December 30, 2016