NCT03121456

18F-FDG PET Scan and MRI Diffusion.Evaluation of the Early Therapeutic Response of Diffuse Large B-cell Lymphoma

18F-FDG PET Scan and MRI Diffusion : Correlation Study of the Evaluation of the Early Therapeutic Response of Diffuse Large B-cell Lymphoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Open-label, multicenter, uncontrolled and non-randomized study comparing 18F-FDG PET-Scan and diffusion MRI in the assessment of the early therapeutic response of Diffuse Large B-Cell Lymphoma.

Detailed description

High-grade lymphomas are characterized by noisy symptomatology and quick progression kinetics in the absence of treatment. The therapeutic strategy and prognosis of patients depend on the initial staging and evaluation of early therapeutic response. Positron emission tomography injected with labeled fluorodeoxyglucose (18F-FDG PET-CT) is recommended in the initial disease balance; It also has a prognostic value demonstrated in the evaluation of the intermediate and final response of treatment of malignant non-Hodgkin's lymphoma B (LMNH B) to large cells through a qualitative visual analysis using the 5-point scale of Deauville, but also thanks to a quantitative analysis with the measurement of the Delta SUV max. If the 18F-FDG PET-CT is referred to, it is not without constraint, it is notably an examination leading to exposure to ionizing radiation for the patient. Diffusion MRI (DWI) is a non-irradiating technique based on the evaluation of the diffusion of water molecules allowing indirect qualitative and quantitative analysis of the tumor microstructure, cellularity and integrity of the cell membrane . The tumor is thus detected thanks to its hypercellularity and the mapping of the apparent diffusion coefficient (ADC). Several recent studies have demonstrated the feasibility and interest of MRI scattering and measurement of CDA in tumor staging and early therapeutic evaluation of high grade lymphomas and more particularly diffuse large B-cell Lyphoma, The latter being characterized by a high nucleo-cytoplasmic cellularity and ratio which makes it possible to obtain a strong signal and low ADC values in diffusion MRI (5) (7) (8) (9) (10) (12) (13) (14). However, there are few studies comparing these two imaging techniques in the therapeutic evaluation of large cell LMNH B (6) (11) (15). The main limitations of the existing studies are their small size and, above all, the accuracy of the methodology for quantifying the measurement of therapeutic response and in particular in terms of quantitative analysis of CDA.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
OTHER	18F-FDG PET SCAN	REALIZATION OF INITIAL 18F-FDG PET SCAN (PRE THERAPEUTIC), THEN BETWEEN CYCLE 2 DAY 10 AND CYCLE 3 DAY 1
OTHER	MRI DIFFUSION	REALIZATION OF INITIAL MRI DIFFUSION WITHIN 7 DAYS AFTER INITIAL 18F-FDG PET SCAN, THEN WITHIN 7 DAYS AFTER 18F-FDG PET SCAN 1.

Timeline

• Start date: 2017-10-13
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2017-04-20
• Last updated: 2023-11-13

Locations

1 site across 1 country: France