The Role of 18F-FDG-PET for Staging and Prognostication

Fondazione Italiana Linfomi - ETS

Status: Completed

Conditions: Mantle Cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT04600804

FIL_MCL0208-PET

Details and patient eligibility

About

A retrospective, multicenter, non-interventional, imaging study ancillary to FIL_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.

Full description

This is a retrospective, multicenter, non-interventional, imaging study devoted to patients diagnosed with MCL and enrolled in the MCL0208 international randomized, phase III clinical trial (NCT02354313).

The study is aimed at addressing a number of prognostic issues that still need to be clarified in MCL patients, by taking advantage of the PET performed within the MCL0208 trial and available for the analysis, and the clinical records and molecular data generated in the context of the trial.

In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after-ASCT (eot-PET), and none of the exams was used in the decisionmaking strategy. All the PETs available will be collected and considered for analysis. The study will not require additional treatment or procedures except those required for the MCL0208 trial. The participation of the patient to the MCL0208 trial is a pre-requisite to be involved in this study.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Enrollment of the patient in the MCL0208 clinical trial documented by the signature of the study informed consent;
• Patient's treatment in one of the centers that participated in the MCL0208 trial and that has joined the MCL0208-PET study as well;
• Evidence of signed informed consent for the MCL0208-PET study.

Trial design

200 participants in 1 patient group

All patients registered in the MCL0208 trial

Description:

About 200 patients enrolled in the MCL0208 trial who performed the PET exams within the clinical trial and who consent to the present study: all PETs available at each center participating in this study will be collected and analyzed. In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after- ASCT (eot-PET). All the PETs available per patient will be collected and considered for analysis, both in the case PET are available at all the 3 time points above listed and in case of availability of PET at 1 or 2 time points only.