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FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00559377
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : June 26, 2015
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 Cervical Adenocarcinoma
Cervical Squamous Cell Carcinoma
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Interventions Other: 18F-fluoromisonidazole
Radiation: fluorodeoxyglucose F 18
Procedure: positron emission tomography
Other: tissue oxygen measurement
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic (^18F FMISO PET and ^18F FDG PET)
Hide Arm/Group Description Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
Period Title: Overall Study
Started 16
Completed 7
Not Completed 9
Reason Not Completed
Withdrawal by Subject             9
Arm/Group Title All Patients
Hide Arm/Group Description Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
16
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.
Time Frame For up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient has been lost to follow up for survival measures.
Arm/Group Title 2 Year Overall Survival
Hide Arm/Group Description:
Patients who have not been declared deceased for 2 years after their last FMISO scan.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants still alive after 2 years
11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 Year Overall Survival
Comments This outcome is for comparing FMISO Hypoxic Volume to overall survival
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .42
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2 Year Overall Survival
Comments This outcome is for comparing FMISO T:Bmax to overall survival
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .87
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Estimation Comments [Not Specified]
2.Primary Outcome
Title Disease-free Survival (DFS)
Hide Description Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 13 patients analyzed for disease-free survival, 10 remained disease-free throughout the 2 year follow up. For 3 patients, we could determine overall survival, but could not confirm whether or not they were disease-free.
Arm/Group Title Disease-Free Survival
Hide Arm/Group Description:
Patients who have remained disease-free throughout the 2 year follow up
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants disease-free after 2 years
10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Disease-Free Survival
Comments This outcome is for comparison of FMISO Hypoxic Volume to disease-free survival
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .58
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Disease-Free Survival
Comments This outcome is for comarison of FMISO T:Bmax to progression-free survival
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .98
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .99
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor
Hide Description The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
11 tissue samples with Hif1, VEGF, p53 and EGFR IHC values were compared to FMISO uptake.
Arm/Group Title Patients With IHC Measures
Hide Arm/Group Description:
Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: units on a scale 0=low, 8=high
Hif1
5
(3 to 7)
VEGF
5
(0 to 7)
p53
7
(4 to 8)
EGFR
7
(3 to 8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients With IHC Measures
Comments The correlation between IHC values and FMISO uptake were analyzed using Spearman correlation where p values less than 0.05 were considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Spearman Correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Spearman Correlation
Estimated Value .004
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Relationship Between Ki67 and Regional FMISO Uptake in Tumor
Hide Description The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
11 tissue samples with Ki67 values were compared to FMISO uptake.
Arm/Group Title Patients With IHC Measures
Hide Arm/Group Description:
Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percentage of staining
74  (18)
5.Secondary Outcome
Title Response to XRT Using RECIST
Hide Description Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols
Time Frame time to disease progression or 2 years following first FMISO scan
Hide Outcome Measure Data
Hide Analysis Population Description
PET/CT acquisition was obtained using non-diagnostic low dose CT attenuation scans at the time of PET/CT imaging that limited our ability to accurately measure tumor dimensions and due to lack of complete data, we were not able to fulfill this aim.
Arm/Group Title Patients Who Had Response Determined by Clinical RECIST
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame As a PET imaging study, AEs are assessed at 3 hours post injection (end of the scan) and up to 10 hours following the scan
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic (^18F FMISO PET and ^18F FDG PET)
Hide Arm/Group Description Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
All-Cause Mortality
Diagnostic (^18F FMISO PET and ^18F FDG PET)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diagnostic (^18F FMISO PET and ^18F FDG PET)
Affected / at Risk (%)
Total   0/16 (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 FMISO PET and ^18F FDG PET)
Affected / at Risk (%)
Total   0/16 (0.00%) 
Small number of subjects enrolled and events limit meaningful statistical analysis.
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: Joseph G Rajendran
Organization: UWMC Dept of Radiology
Phone: 206-221-4421
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00559377     History of Changes
Other Study ID Numbers: NCI-2009-00257
NCI-2009-00257 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UW IRB# 6143 ( Other Identifier: University of Washington Medical Center )
7958 ( Other Identifier: CTEP )
N01CM37008 ( Other Identifier: US NIH Grant/Contract Award Number: )
First Submitted: November 15, 2007
First Posted: November 16, 2007
Results First Submitted: October 29, 2014
Results First Posted: June 26, 2015
Last Update Posted: December 30, 2016