Trial Outcomes & Findings for Perfusion CT in Predicting Outcomes in Ovarian, Fallopian, or Peritoneal Cancer With Bevacizumab (NCT NCT03412630)
NCT ID: NCT03412630
Last Updated: 2023-11-24
Results Overview
The PFS of patients with increased tumor blood flow (BF) from T0 to T1 will be compared with that of patients with decreased tumor BF from T0 to T1. Kaplan-Meier survival curves will be generated, and a two-sided log-rank test will be used to compare PFS between the two groups.
TERMINATED
NA
1 participants
Time to progression or death from the T1 scan, assessed up to 18 months
2023-11-24
Participant Flow
The first patient was accrued on December 13, 2018.
Participant milestones
| Measure |
Diagnostic (Computed Tomography Perfusion Imaging)
Patients undergo computed tomography perfusion imaging at baseline and on day 15 after initiation of standard of care bevacizumab treatment and before the second dose.
Computed Tomography Perfusion Imaging: Undergo computed tomography perfusion imaging
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Numbers not provided to comply with HIPAA
Baseline characteristics by cohort
| Measure |
Diagnostic (Computed Tomography Perfusion Imaging)
n=1 Participants
Patients undergo computed tomography perfusion imaging at baseline and on day 15 after initiation of standard of care bevacizumab treatment and before the second dose.
Computed Tomography Perfusion Imaging: Undergo computed tomography perfusion imaging
|
|---|---|
|
Sex: Female, Male
Female
|
0 Participants
Numbers not provided to comply with HIPAA
|
|
Sex: Female, Male
Male
|
0 Participants
Numbers not provided to comply with HIPAA
|
PRIMARY outcome
Timeframe: Time to progression or death from the T1 scan, assessed up to 18 monthsPopulation: Analysis not performed due to lack of data. Only 1 participant was accrued and available for analysis. This is insufficient for any meaningful statistical analysis and thus no analyses were performed. To comply with HIPAA requirements, all data and results for this participant been suppressed .
The PFS of patients with increased tumor blood flow (BF) from T0 to T1 will be compared with that of patients with decreased tumor BF from T0 to T1. Kaplan-Meier survival curves will be generated, and a two-sided log-rank test will be used to compare PFS between the two groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Analyses not performed due to lack of data. Only 1 participant was accrued and available for analysis. This is insufficient for any meaningful statistical analysis and thus no analyses were performed. To comply with HIPAA requirements, all data and results for this participant been suppressed .
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1.
Outcome measures
Outcome data not reported
Adverse Events
Diagnostic (Computed Tomography Perfusion Imaging)
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
- Publication restrictions are in place
Restriction type: LTE60