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Fluorodeoxyglucose F18

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.

Michael Mian, MD

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

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.

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

The Role of 18F-FDG-PET for Staging and Prognostication in Patients Enrolled in the Fondazione Italiana Linfomi (FIL) MCL0208 Trial

To better define the role of PET for the staging of MCL patients at the time of diagnosis, for evaluation of response after induction treatment (pre-ASCT; i-PET) and post ASCT (eot-PET) in comparison to the current standards, namely computed axial tomography (CT) and bone marrow biopsy.

To build a new prognostic model for PFS, including PET parameters, MIPI-b and biological data (e.g. MRD, GEP and mutational parameters).The achievement of these objectives could help to plan futures studies in order to improve the outcome of MCL patients.

Fondazione Italiana Linfomi - ETS

Study title	NCT ID	Conditions	Eligibility	Organization
The Role of 18F-FDG-PET for Staging and Prognostication	NCT04600804	Mantle Cell Lym...	18 Years -	Fondazione Italiana Linfomi - ETS
The Role of 18F-FDG-PET for Staging and Prognostication	NCT04600804	Mantle Cell Lym...	18 Years -	Fondazione Italiana Linfomi - ETS
The Role of 18F-FDG-PET for Staging and Prognostication	NCT04600804	Mantle Cell Lym...	18 Years -	Fondazione Italiana Linfomi - ETS
The Role of 18F-FDG-PET for Staging and Prognostication	NCT04600804	Mantle Cell Lym...	18 Years -	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for prognostic issues