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

NCT ID: NCT00645359

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2014-04-30

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.

Detailed Description

Different types of functional imaging are under investigation as a tool to predict response to treatment, as imaging soon after starting therapy might be able to better define the likelihood of response. Functional imaging refers to scans that measure characteristics other than size and shape (anatomic imaging), as measured by CT scans. We are interested in evaluating the potential value of diffusion Magnetic Resonance Imaging (dMRI), which in some settings can be used very early in treatment in predicting patients' response to treatment.

Diffusion MRI (dMRI) detects changes in cell structure, and has the potential to detect and measure cell changes that occur in response to treatment. Several groups are investigating the use of dMRI to monitor treatment responses. This strategy has been most frequently explored in humans in patients with brain tumors, where dMRI has been demonstrated to predict response to treatment early after starting treatment. A few studies have looked at response in other cancers. These studies showed early changes in patients who later responded to treatment, with changes seen within one to 2 weeks.

Although diffusion MRI has been shown to be useful in several cancer types, it has not been explored in the evaluation of lymphoma. This pilot study will evaluate the imaging characteristics of Diffuse Large B-Cell Lymphoma (DLBCL) by dMRI prior to treatment and 7 days after initial chemotherapy in order to explore whether dMRI is useful in evaluating the response of lymphoma to chemotherapy.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diffusion MRI

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

diffusion MRI

Intervention Type: 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.

Interventions

diffusion MRI

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.

Intervention Type: PROCEDURE

Other Intervention Names

dMRI, diffusion MRI, diffusion Magnetic Resonance Imaging

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM 6946

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2006.063

Identifier Type: -

Identifier Source: org_study_id