An observational study in Hodgkin Lymphoma and B-Cell Lymphoma, sponsored by The Lymphoma Academic Research Organisation. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by The Lymphoma Academic Research Organisation · Observational
The present study aims to further optimize a whole-body Diffusion-Weighted Magnetic Resonance Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla MR and Positron Emission Tomography (PET), to develop and validate an automated whole-body parametric image analysis algorithm, and to determine the added value of whole-body DWI to Fluorodeoxyglucose-PET for the management of lymphoma patients.
Imaging biomarkers are important tools for the detection and characterization of cancers as well as for monitoring the response to therapy. "Whole-body" molecular imaging, in particular using 18-Fluorodeoxyglucose-PET, has been proven useful in the evaluation and management of lymphoma patients. FDG-PET has evolved as a valuable biomarker in aggressive lymphomas, which is the current state-of-the-art imaging technique for response assessment at the end of treatment. Additionally, the prognostic value of "interim" (during treatment) or early PET has been well established in Hodgkin lymphoma and diffuse large B-cell lymphoma, which together account for more than 50% of all lymphomas. Worldwide clinical trials are ongoing to evaluate risk-adapted individualized treatment strategy based on interim PET results. Therefore, uniform and evidence-based guidelines for the interpretation are warranted. International Workshop on Interim PET in Lymphoma recently proposed a 5-point score method and so far the results of validation studies are promising.
However, one could speculate that the risk of false-positive studies due to a non-specific inflammatory effect will be greater when patients receiving more toxic regimens and the usefulness of imaging biomarkers would vary for different lymphoma subtypes. Meanwhile, thanks to rapid technical development, whole-body functional magnetic resonance imaging (MRI) in particular diffusion-weighted MRI (DWI) reflecting cell density is now feasible in the clinical setting. Quantitative parameters derived from DWI reflecting cell density may provide complementary information to current state-of-the-art FDG-PET imaging reflecting quantitatively glucose metabolism and prove to be helpful in patient management.
Pilot studies have shown the potential of whole-body DWI in lymphomas for staging and response assessment on 1.5 Tesla MR system but larger-scaled prospective studies are required before this new imaging-based biomarker can ever be validated for routine clinical use. Besides, technical challenges remain especially when encountering higher-field clinical MR systems. Finally, a vast amount of information generated from whole-body parametric imaging data will require development of automated image analysis software, which may help in establishing a multi-parametric approach in characterizing residual lymphoma masses.
Therefore, the present study aims to further optimize a whole-body DWI protocol on 3 Tesla MR and/or new system combining 3Tesla MR and PET, to develop and validate an automated whole-body parametric image analysis algorithm, and to determine the added value of whole-body DWI to FDG-PET for the management of lymphoma patients.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 120 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →The Lymphoma Academic Research Organisation is the lead sponsor of 60 studies on the registry; 12 are open to participants now.
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Newly diagnosed HL, DLBCL or FL At least 18 years of age Initial presentation of bulky disease
Exclusion Criteria:
apparent diffusion coefficient changes of post-treatment residual lymphoma masses and whether this MR-derived parameter helps in characterizing its viability in addition to PET
Time frame: Baseline
correlation between standardized uptake value and apparent diffusion coefficient changes; correlation with post-treatment histopathological findings if tissue proof
Time frame: Baseline, 6 weeks, between 18 and 24 weeks
correlation between the PET and MR-derived functional parameters with clinical outcome (end-treatment response and survival)
Time frame: Between 18 and 24 weeks
development of automated lesion detection algorithm
Time frame: Baseline, 6 weeks, between 18 and 24 weeks
texture analysis of the major lymphoma mass and correlation of tumor heterogeneity with treatment outcome
Time frame: Baseline, 6 weeks, between 18 and 24 weeks
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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The Lymphoma Academic Research Organisation