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Whole-body Diffusion-weighted Magnetic Resonance Imaging for Staging and Treatment Prediction of Lymphoma

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ClinicalTrials.gov Identifier: NCT01231269
Recruitment Status : Unknown
Verified September 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Active, not recruiting
First Posted : November 1, 2010
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted-images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native DWI images and low ADC. Several studies indicate the value of DWI for differentiation of benign and malignant lymph nodes, detection of tumor recurrence and for ADC-based prediction of treatment outcome in various solid tumours (Koh DM et al, Am J Roentgenol 2007).

Patients with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and PTLD) will be included in the study. These patients will receive a WB-DWI scan before treatment, once or twice during treatment (depending on the type of lymphoma) and after the completion of the treatment. The MRI scan will be performed on a 3 Tesla-MRI system without contrast administration and without exposing the patient to radiation.

Whole body diffusion-weighted images will be prospectively interpreted by two experienced radiologists, blinded to all clinical and imaging data. Findings will be correlated to FDG-18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose , biopsies performed in clinical routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up.

The purpose of this study is:

  • to evaluate Whole body diffusion-weighted imaging for staging of lymphoma
  • to evaluate Whole body diffusion-weighted imaging as an early predictive biomarker for treatment outcome
  • to evaluate Whole body diffusion-weighted imaging for differentiating residual tumor from post therapy changes

Condition or disease Intervention/treatment Phase
Lymphoma Hodgkin Lymphoma Non-Hodgkin Lymphoma (Follicular, Diffuse B-cel Lymphoma, PTLD and Mantle Cel Lymphoma) Other: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Whole-body Diffusion-weighted Magnetic Resonance Imaging for Staging and Treatment Prediction of Lymphoma
Study Start Date : November 2010
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI
diffusion-weighted MRI
Other: MRI
MRI scan without administration of contrast/without radiation




Primary Outcome Measures :
  1. disease stage [ Time Frame: 4 years ]
    Lesions are characterized as benign or malignant based on signal intensity and ADC values, enabling correct determination of tumor extent (staging).


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 6 years ]
    We will investigate whether there is a correlation between ADC and signal intensity changes during therapy and progression free survival



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • every patient with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cel lymphoma, mantle cell lymphoma, follicular lymphoma and PTLD)

Exclusion Criteria:

  • patient with general contraindications for MRI (pacemaker, claustrophobia, etc.)
  • patients with a type of lymphoma other than those described in the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231269


Locations
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Belgium
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: vincent vandecaveye, MD PhD University Hospitals Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01231269     History of Changes
Other Study ID Numbers: S51160
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: September 2010

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases