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

This study is currently recruiting participants.
Study NCT00645359.   Last updated on October 10, 2008.   Information provided by University of Michigan Cancer Center

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Descriptive Information Fields
Brief Title  Pilot Study of dMRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B-Cell Lymphoma
Official Title  Pilot Study of Diffusion MRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B Cell Lymphoma
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 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 Phase
Study Type  Observational
Study Design 
Primary Outcome Measure  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 ]
Secondary Outcome Measure 
Condition  Diffuse Large B Cell Lymphoma
Intervention  Procedure: diffusion MRI
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  20
Start Date  November 2006
Completion Date January 2011
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Cancer Answer Line     1-800-865-1125        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00645359
Organization ID UMCC 2006.063
Secondary IDs †† HUM 6946
Study Sponsor  University of Michigan Cancer Center
Collaborators ††
Investigators 
Information Provided By University of Michigan Cancer Center
Verification Date October 2008
First Received Date  March 24, 2008
Last Updated Date October 10, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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