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[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers

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ClinicalTrials.gov Identifier: NCT01717391
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : September 5, 2017
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John M. Buatti, University of Iowa

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Uterine Cervical Neoplasms
Endometrial Neoplasms
Anus Neoplasms
Rectal Neoplasms
Prostatic Neoplasms
Intervention Drug: fluorothymidine F 18
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FLT PET/CT
Hide Arm/Group Description

FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.

Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.

Period Title: Overall Study
Started 36
Completed 27
Not Completed 9
Reason Not Completed
Withdrawal by Subject             5
Physician Decision             1
FLT technical failure             3
Arm/Group Title FLT PET/CT
Hide Arm/Group Description

FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.

Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  80.6%
>=65 years
7
  19.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
24
  66.7%
Male
12
  33.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
 100.0%
1.Primary Outcome
Title Percent Difference From Baseline IMRT Plan (%)
Hide Description The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.
Time Frame Baseline (pre-treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received an FLT PET/CT during radiation simulation.
Arm/Group Title Basline FLT PET/CT (All Subjects)
Hide Arm/Group Description:
FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: Percent difference (%)
% difference, volume receiving 5 Gray -4.7  (3.3)
% difference, volume receiving 10 Gray -9.3  (4.2)
% difference, volume receiving 20 Gray -14.2  (4.1)
% difference, volume receiving 30 Gray -13.4  (7.6)
% difference, dose to target (tumor) volume -0.1  (0.4)
2.Secondary Outcome
Title Chemotherapy Compliance
Hide Description The number of participants who had chemotherapy withheld at least once for low blood counts.
Time Frame At 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FLT PET/CT
Hide Arm/Group Description:

FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.

Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.

Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
7
  25.9%
3.Secondary Outcome
Title Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Hide Description White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up
Time Frame baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This group includes all tumor types treated in this clinical trial and provides an overall averages.
Arm/Group Title Bone-marrow Sparing Radiation Therapy (IMRT)
Hide Arm/Group Description:
Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (pre-treatment) Grade 0 (no toxicity)
27
 100.0%
CTCAE grade 1
0
   0.0%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 1 Grade 0 (no toxicity)
27
 100.0%
CTCAE grade 1
0
   0.0%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 2 Grade 0 (no toxicity)
15
  55.6%
CTCAE grade 1
7
  25.9%
CTCAE grade 2
1
   3.7%
CTCAE grade 3
3
  11.1%
CTCAE grade 4 (most severe)
1
   3.7%
Not assessed (test omitted)
0
   0.0%
Therapy, week 3 Grade 0 (no toxicity)
13
  48.1%
CTCAE grade 1
5
  18.5%
CTCAE grade 2
2
   7.4%
CTCAE grade 3
1
   3.7%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
6
  22.2%
Therapy, week 4 Grade 0 (no toxicity)
13
  48.1%
CTCAE grade 1
5
  18.5%
CTCAE grade 2
4
  14.8%
CTCAE grade 3
2
   7.4%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
3
  11.1%
Therapy, week 5 Grade 0 (no toxicity)
10
  37.0%
CTCAE grade 1
3
  11.1%
CTCAE grade 2
3
  11.1%
CTCAE grade 3
1
   3.7%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
10
  37.0%
30 days post-therapy Grade 0 (no toxicity)
20
  74.1%
CTCAE grade 1
2
   7.4%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
5
  18.5%
1 year post-therapy Grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
1
   3.7%
CTCAE grade 2
1
   3.7%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
9
  33.3%
4.Secondary Outcome
Title Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Hide Description Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Time Frame baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This group includes all tumor types treated in this clinical trial and provides an overall averages.
Arm/Group Title Bone-marrow Sparing Radiation Therapy (IMRT)
Hide Arm/Group Description:
Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (pre-treatment) CTCAE grade 0 (no toxicity)
27
 100.0%
CTCAE grade 1
0
   0.0%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (severe toxicity)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 1 CTCAE grade 0 (no toxicity)
27
 100.0%
CTCAE grade 1
0
   0.0%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (severe toxicity)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 2 CTCAE grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
9
  33.3%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
2
   7.4%
CTCAE grade 4 (severe toxicity)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 3 CTCAE grade 0 (no toxicity)
12
  44.4%
CTCAE grade 1
6
  22.2%
CTCAE grade 2
1
   3.7%
CTCAE grade 3
1
   3.7%
CTCAE grade 4 (severe toxicity)
0
   0.0%
Not assessed (test omitted)
7
  25.9%
Therapy, week 4 CTCAE grade 0 (no toxicity)
15
  55.6%
CTCAE grade 1
6
  22.2%
CTCAE grade 2
2
   7.4%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (severe toxicity)
0
   0.0%
Not assessed (test omitted)
4
  14.8%
Therapy, week 5 CTCAE grade 0 (no toxicity)
9
  33.3%
CTCAE grade 1
7
  25.9%
CTCAE grade 2
1
   3.7%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (severe toxicity)
0
   0.0%
Not assessed (test omitted)
10
  37.0%
30 days post-therapy CTCAE grade 0 (no toxicity)
17
  63.0%
CTCAE grade 1
4
  14.8%
CTCAE grade 2
1
   3.7%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (severe toxicity)
0
   0.0%
Not assessed (test omitted)
5
  18.5%
1 year post-therapy CTCAE grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
2
   7.4%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (severe toxicity)
0
   0.0%
Not assessed (test omitted)
9
  33.3%
5.Secondary Outcome
Title Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Hide Description Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Time Frame baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This group includes all tumor types treated in this clinical trial and provides an overall averages.
Arm/Group Title Bone-marrow Sparing Radiation Therapy (IMRT)
Hide Arm/Group Description:
Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (pre-treatment) CTCAE grade 0 (no toxicity)
27
 100.0%
CTCAE grade 1
0
   0.0%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 1 CTCAE grade 0 (no toxicity)
25
  92.6%
CTCAE grade 1
2
   7.4%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 2 CTCAE grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
8
  29.6%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
1
   3.7%
CTCAE grade 4 (most severe)
2
   7.4%
Not assessed (test omitted)
0
   0.0%
Therapy, week 3 CTCAE grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
4
  14.8%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
1
   3.7%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
6
  22.2%
Therapy, week 4 CTCAE grade 0 (no toxicity)
17
  63.0%
CTCAE grade 1
5
  18.5%
CTCAE grade 2
2
   7.4%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
3
  11.1%
Therapy, week 5 CTCAE grade 0 (no toxicity)
13
  48.1%
CTCAE grade 1
2
   7.4%
CTCAE grade 2
2
   7.4%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
10
  37.0%
30 days post-therapy CTCAE grade 0 (no toxicity)
21
  77.8%
CTCAE grade 1
1
   3.7%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
5
  18.5%
1 year post-therapy CTCAE grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
2
   7.4%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
9
  33.3%
6.Secondary Outcome
Title Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Hide Description Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Time Frame baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This group includes all tumor types treated in this clinical trial and provides an overall averages.
Arm/Group Title Bone-marrow Sparing Radiation Therapy (IMRT)
Hide Arm/Group Description:
Participants who have undergone the FLT PET/CT imaging ordered pre-radiation therapy to create a patient-specific bone marrow map to spare active bone marrow.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (pre-treatment) CTCAE grade 0 (no toxicity)
27
 100.0%
CTCAE grade 1
0
   0.0%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 1 CTCAE grade 0 (no toxicity)
25
  92.6%
CTCAE grade 1
2
   7.4%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
0
   0.0%
Therapy, week 2 CTCAE grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
8
  29.6%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
1
   3.7%
CTCAE grade 4 (most severe)
2
   7.4%
Not assessed (test omitted)
0
   0.0%
Therapy, week 3 CTCAE grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
4
  14.8%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
1
   3.7%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
6
  22.2%
Therapy, week 4 CTCAE grade 0 (no toxicity)
17
  63.0%
CTCAE grade 1
5
  18.5%
CTCAE grade 2
2
   7.4%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
3
  11.1%
Therapy, week 5 CTCAE grade 0 (no toxicity)
13
  48.1%
CTCAE grade 1
2
   7.4%
CTCAE grade 2
2
   7.4%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
10
  37.0%
30 days post-therapy CTCAE grade 0 (no toxicity)
21
  77.8%
CTCAE grade 1
1
   3.7%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
5
  18.5%
1 year post-therapy CTCAE grade 0 (no toxicity)
16
  59.3%
CTCAE grade 1
2
   7.4%
CTCAE grade 2
0
   0.0%
CTCAE grade 3
0
   0.0%
CTCAE grade 4 (most severe)
0
   0.0%
Not assessed (test omitted)
9
  33.3%
Time Frame Adverse events were collected for 48 hours after injection with FLT, the investigational drug under study.
Adverse Event Reporting Description Adverse events were collected through medical chart review as well as by direct contact by a licensed health provider with participant for their perceived side effects from the FLT PET/CT scan. Chart review is considered non-systematic collection; the semi-structured interview 48 hours after the scan is considered a systematic collection. Grade 0 is considered no toxicity (symptom is absent) and grade 4 is considered the most severe toxicity.
 
Arm/Group Title FLT PET/CT
Hide Arm/Group Description

FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.

Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.

All-Cause Mortality
FLT PET/CT
Affected / at Risk (%)
Total   0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FLT PET/CT
Affected / at Risk (%) # Events
Total   0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FLT PET/CT
Affected / at Risk (%) # Events
Total   6/27 (22.22%)    
Gastrointestinal disorders   
Diarrhea, grade 1 * 1  3/27 (11.11%)  5
Diarrhea, grade 2 * 1  2/27 (7.41%)  2
Nausea, grade 1 * 1  6/27 (22.22%)  6
Nervous system disorders   
Headache, grade 1  1  2/27 (7.41%)  2
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: John M. Buatti, MD
Organization: The University of Iowa
Phone: 319-356-2699
Responsible Party: John M. Buatti, University of Iowa
ClinicalTrials.gov Identifier: NCT01717391     History of Changes
Other Study ID Numbers: 201204712
R01CA169336 ( U.S. NIH Grant/Contract )
First Submitted: October 18, 2012
First Posted: October 30, 2012
Results First Submitted: June 30, 2017
Results First Posted: September 5, 2017
Last Update Posted: July 31, 2018