Trial Outcomes & Findings for [18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers (NCT NCT02108457)
NCT ID: NCT02108457
Last Updated: 2021-03-30
Results Overview
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
up to 5 weeks
Results posted on
2021-03-30
Participant Flow
Participant milestones
| Measure |
Proton Subjects
\[18F\]Fluorothymidine (FLT) PET/CT Imaging
|
IMRT Subjects
\[18F\]Fluorothymidine (FLT) PET/CT Imaging
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
|
Overall Study
COMPLETED
|
3
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
[18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers
Baseline characteristics by cohort
| Measure |
Proton Subjects
n=3 Participants
\[18F\]Fluorothymidine (FLT) PET/CT Imaging
|
IMRT Subjects
n=12 Participants
\[18F\]Fluorothymidine (FLT) PET/CT Imaging
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 19.2 • n=93 Participants
|
47.8 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
46.9 years
STANDARD_DEVIATION 14.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
12 participants
n=4 Participants
|
15 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 5 weeksOutcome measures
| Measure |
Proton Subjects
n=3 Participants
\[18F\]Fluorothymidine (FLT) PET/CT Imaging
|
IMRT Subjects
n=12 Participants
\[18F\]Fluorothymidine (FLT) PET/CT Imaging
|
|---|---|---|
|
Patients With Changes in Bone Marrow Assessed Through Images
|
0 Participants
|
4 Participants
|
Adverse Events
Proton Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IMRT Subjects
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Proton Subjects
n=3 participants at risk
\[18F\]Fluorothymidine (FLT) PET/CT Imaging
|
IMRT Subjects
n=12 participants at risk
\[18F\]Fluorothymidine (FLT) PET/CT Imaging
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
16.7%
2/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/3
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place