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

March 16, 2017 updated by: University of Michigan Rogel Cancer Center

Pilot Study of Diffusion MRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B Cell Lymphoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diffusion MRI
Patients will undergo a Diffusion MRI (dMRI) at baseline and 7 days.
Procedure: 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.
Other Names:
  • dMRI, diffusion MRI, diffusion Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Difference in Apparent Diffusion Coefficient
Time Frame: Baseline and Day 8
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
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2006.063
  • HUM 6946 (Other Identifier: University of Michigan Medical School IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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