Trial Outcomes & Findings for Pilot Study of dMRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B-cell Lymphoma (NCT NCT00645359)
NCT ID: NCT00645359
Last Updated: 2017-04-14
Results Overview
To assess whether changes in the apparent diffusion coefficient (ADC) during the early phase of chemotherapy are detectable in lymphoma, the ADC value will be calculated at the voxel level, on baseline and Day 8, and the mean difference will be calculated.
TERMINATED
9 participants
Baseline and Day 8
2017-04-14
Participant Flow
Participant milestones
| Measure |
Diffusion MRI
Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of dMRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Diffusion MRI
n=9 Participants
Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 8Population: No patients were analyzed due to insufficient resources, secondary to shifting research priorities.
To assess whether changes in the apparent diffusion coefficient (ADC) during the early phase of chemotherapy are detectable in lymphoma, the ADC value will be calculated at the voxel level, on baseline and Day 8, and the mean difference will be calculated.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 yearsPopulation: No patients were analyzed due to insufficient resources, secondary to shifting research priorities.
To correlate the changes on MR images with the tumor response after completion of chemotherapy and duration of response. Tumor response will be determined by the clinical evaluation, tumor dimensions, and metabolic response as assessed by 18-Fluoro-deoxy.
Outcome measures
Outcome data not reported
Adverse Events
Diffusion MRI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Daniel Lebovic, M.D.
University of Michigan Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place