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

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ClinicalTrials.gov Identifier: NCT03121456
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Brief 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.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Other: 18F-FDG PET SCAN Other: MRI DIFFUSION Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-FDG PET Scan and MRI Diffusion : Correlation Study of the Evaluation of the Early Therapeutic Response of Diffuse Large B-cell Lymphoma
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : April 12, 2024
Estimated Study Completion Date : April 12, 2024


Arm Intervention/treatment
Experimental: 18F-FDG PET SCAN

REALIZATION OF INITIAL 18F-FDG PET SCAN (PRE THERAPEUTIC), THEN BETWEEN CYCLE 2 DAY 10 AND CYCLE 3 DAY 1

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.

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.




Primary Outcome Measures :
  1. measurement of the correlation between the Delta SUVmax in PET-TDM (or between the Deauville criteria if the Delta SUVmax is not applicable) and the Delta ADCmax in diffusion MRI. [ Time Frame: up to 2 years ]
    scattering MRI in the assessment of the early therapeutic response of diffuse large cell Lymphoma.


Secondary Outcome Measures :
  1. progression free-survival at 2 years [ Time Frame: up to 2 years ]
    Progression-free survival will be assessed between the date of diagnosis and the date of death (any cause) or progression (according to RECIST 1.1) within two years after inclusion.

  2. diagnostic performance of MRI scattering [ Time Frame: Up to 4 years ]
    The diagnostic performance of MRI scattering will be assessed using the following parameters: sensitivity, specificity, positive predictive value (PPV) and negative predictive value (PNP), positive and negative likelihood ratios, area under the ROC as well as the Youden Index. An optimal threshold of the Delta ADCmax will be defined, which will then correspond to a maximum Youden index.

  3. - The degree of inter- and intra-observer association (concordance) of the ADCmax [ Time Frame: up to 4 years ]
    The degree of inter- and intra-observer association (concordance) of the ADCmax will be calculated using the intra-class correlation coefficient (ICC). A representation of Bland and Altman will also be performed in addition to the ICC calculation



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with Diffuse Large B-Cell Lymphoma confirmed histologically
  • Patient with a tumor mass defined as measurable according to the RECIST 1.1 criteria,
  • Patient requiring a standard first-line chemotherapy treatment (Rituximab -Cyclophosphamide - Hydroxyadriamycin - Oncovin - Prednisone = R-CHOP every 21 days),
  • Patient older than 18 years,
  • Performance status less than or equal to 2,
  • Biological assessment meeting the following criteria: creatinine <150 μmol / l or creatinine clearance> 40 ml / min, total bilirubin <30 μmol / l, transaminases <2.5 x ULN
  • Patient of childbearing age must agree to use Means of effective contraception during the treatment period,
  • Patient having read the information note and having signed informed consent,
  • Patient with Health care insurance available.

Exclusion Criteria:

  • History of malignant hemopathy or solid tumor
  • History of previous chemotherapy
  • Contraindication to one of the examinations studied (Claustrophobia, Pacemaker ...)
  • Patient included in another clinical trial for which a period of exclusion is mentioned.
  • Patient considered to be a vulnerable person; Vulnerable persons are defined in article L1121-5 to - 8: Pregnant women, women who are pregnant, women who are breastfeeding, Persons deprived of their liberty by a judicial or administrative decision, persons who are hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social institution for purposes other than research Persons who are the subject of a legal protection measure or are unable to give their consent.

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): NCT03121456


Contacts
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Contact: Lauris GASTAUD, Dr +33492031047 lauris.gastaud@nice.unicancer.fr
Contact: Antoine THYSS, Pr +33492031497 antoine.thyss@nice.unicancer.fr

Locations
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France
Centre antoine-LACASSAGNE Recruiting
Nice, France, 06189
Contact: LAURIS GASTAUD, MD    +330492031521    lauris.gastaud@nice.unicancer.fr   
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
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Study Director: Christine LOVERA Centre Antoine Lacassagne
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Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT03121456    
Other Study ID Numbers: 2016/12
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action