Pilot Study of dMRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B-cell Lymphoma

NCT00645359 | Terminated Results DMC

• 2 other identifiers: UMCC 2006.063HUM 6946
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diffuse Large B Cell Lymphoma

Keywords

dMRI; diffusion MRI; Diffuse large B-cell lymphoma; DLBCL

Outcome Measures

Primary Outcomes (2)

• Mean Difference in Apparent Diffusion Coefficient

  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.

  Baseline and Day 8

• The Odds Ratio (OR) Between Tumor Response (Based on Changes in MR Imaging) and Duration of Response

  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.

  2 years

Study Arms (1)

Diffusion MRI

Patients will undergo a Diffusion MRI (dMRI) at baseline and 7 days.

Procedure: diffusion MRI

Interventions

diffusion MRI PROCEDURE

Diffusion MRI involves using MRI scanning to measure water transport at the cellular level. In this study, dMRI is being used to measure the response of tumors to chemotherapy.

Also known as: dMRI, diffusion MRI, diffusion Magnetic Resonance Imaging

Diffusion MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lymphoma of any stage or subtype (including all Hodgkin's and non-Hodgkin's lymphomas), previously untreated or in relapse, who are starting on a new line of therapy with intent to induce a remission.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Limitations and Caveats

This study was not completed due to insufficient resources to evaluate the pilot phase of the study, secondary to shifting research priorities.

Results Point of Contact

• Title: Dr. Daniel Lebovic, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

dlebovic@umich.edu

734-936-5310

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: November 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: April 1, 2014
• Last Updated: April 14, 2017
• Results First Posted: October 8, 2014

Record last verified: 2017-03

Locations

US (1)