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

Sponsor:	University of Michigan Cancer Center
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00645359

Purpose

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.

Condition	Intervention
Diffuse Large B Cell Lymphoma	Procedure: diffusion MRI

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Pilot Study of Diffusion MRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma MRI Scans

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:

To assess whether changes in the apparent diffusion coefficient (ADC) during the early phase of chemotherapy are detectable in lymphoma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 FDG-PET. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2006
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Intervention Details:

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 Name: dMRI, diffusion MRI, diffusion Magnetic Resonance Imaging

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria:

Patients with a new diagnosis of CD20+ 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645359

Contacts

Contact: Cancer Answer Line

1-800-865-1125

Locations

United States, Michigan
University of Michigan Comprehensive Cancer Center	Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Daniel Lebovic, MD
Sub-Investigator: Mark Kaminski, MD
Sub-Investigator: Brian Ross, PHD
Sub-Investigator: Timothy Johnson, PHD
Sub-Investigator: Thomas Chenevert, PHD
Sub-Investigator: Charles Meyer, PHD
Sub-Investigator: Alnawaz Rehemtullah, PHD
Sub-Investigator: Craig Galban, PHD
Sub-Investigator: Hero Hussain, MD

Sponsors and Collaborators

University of Michigan Cancer Center

More Information

No publications provided

Responsible Party:	Daniel Lebovic, MD, Department of Internal Medicine/Hematology/Oncology
ClinicalTrials.gov Identifier:	NCT00645359 History of Changes
Other Study ID Numbers:	UMCC 2006.063, HUM 6946
Study First Received:	March 24, 2008
Last Updated:	July 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:

dMRI
diffusion MRI
Diffuse large B-cell lymphoma
DLBCL

Additional relevant MeSH terms:

Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on February 12, 2012