Trial Outcomes & Findings for A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation (NCT NCT00847509)
NCT ID: NCT00847509
Last Updated: 2013-09-27
Results Overview
The sponsor decided not to further develop \[F-18\]FLT. Therefore, no further analysis was performed.
COMPLETED
NA
49 participants
3-5 weeks after the start of radiation or chemo radio therapy
2013-09-27
Participant Flow
A total of 49 patients were enrolled and 38 patients received investiational product.
Participant milestones
| Measure |
[F-18]FLT PET Scan
Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate \[F-18\] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard \[F-18\] FDG PET will be the active comparator.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation
Baseline characteristics by cohort
| Measure |
[F-18]FLT Scan
n=49 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Age Continuous
|
64.67 years
STANDARD_DEVIATION 10.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-5 weeks after the start of radiation or chemo radio therapyThe sponsor decided not to further develop \[F-18\]FLT. Therefore, no further analysis was performed.
Outcome measures
Outcome data not reported
Adverse Events
[F-18]FLT PET Scan
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The restriction on the PI is that the sponsor can review results communication prior to public release and can embargo communications regarding trial results.
- Publication restrictions are in place
Restriction type: OTHER