Clinical trial · Observational
Pilot Study of dMRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B-cell Lymphoma
Pilot Study of Diffusion MRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B Cell Lymphoma
NCT00645359CI-TRIAL-00026984dMRIterminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient resources to evaluate pilot, second to shift in research priorities
Summary
Brief summary (as posted)
This research study is designed to test whether the results of a diffusion MRI scan performed after one cycle of chemotherapy for lymphoma can accurately predict the outcome of treatment for individual patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diffusion MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diffusion MRI
- description
- Patients will undergo a Diffusion MRI (dMRI) at baseline and 7 days.
- interventionNames
- Procedure: diffusion MRI
Primary outcomes (2)
- measure
- Mean Difference in Apparent Diffusion Coefficient
- timeFrame
- Baseline and Day 8
- description
- 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.
- measure
- The Odds Ratio (OR) Between Tumor Response (Based on Changes in MR Imaging) and Duration of Response
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a new diagnosis of CD20 Positive diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma, who will receive standard R/CHOP as first line chemotherapy will be included. * Patients must be age 18 or older. * No selection will be made on the basis of gender, race or ethnicity. Exclusion Criteria: * Patients will be excluded if the diagnosis of diffuse large B cell lymphoma cannot be confirmed. * Patients receiving treatment other than R/CHOP or R/CHOP followed by radiotherapy or who have previously been treated for DLBCL will be excluded. - Patients with HIV infection will also be excluded. No selection will be made based on other medical problems or laboratory values, except as they affect the patient's eligibility to receive standard R/CHOP chemotherapy as determined by the treating physician. * Patients who have magnetic metal implants or fragments in their body that are incompatible with MRI will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.