Detection and Characterization of Residual Masses in Lymphomas

NCT02300402 | Completed

• 1 other identifier: ADAMANTIUS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hodgkin Lymphoma; B-Cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline

• correlation between standardized uptake value and apparent diffusion coefficient changes; correlation with post-treatment histopathological findings if tissue proof

  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)

  Between 18 and 24 weeks

Other Outcomes (2)

• development of automated lesion detection algorithm

  Baseline, 6 weeks, between 18 and 24 weeks

• texture analysis of the major lymphoma mass and correlation of tumor heterogeneity with treatment outcome

  Baseline, 6 weeks, between 18 and 24 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed HL, DLBCL or FL At least 18 years of age Initial presentation of bulky disease

You may qualify if:

• Newly diagnosed hodgkin's lymphoma, diffuse large B-cell lymphoma or follicular lymphoma
• Patients aged over 18
• Initial presentation of bulky disease

You may not qualify if:

• Patients with impaired central nervous system
• Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
• Patients with low kidney and/or liver function
• Patients with HIV +
• Patients whose life expectancy ≤ 6 months
• Patients with other medical problems or psychological susceptibles interfere with the study,
• Patients under adult supervision.

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead

Study Sites (1)

Hopital Henri Mondor

Créteil, 94010, France

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Study Officials

• Alain Rahmouni, Prof.

  CHU Henri Mondor

  PRINCIPAL INVESTIGATOR

• Corinne Haioun, Prof.

  Lymphoma Study Association

  PRINCIPAL INVESTIGATOR

• Emmanuel Itti, Prof.

  CHU Henri Mondor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: November 25, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)