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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ematologia Ospedale Vito Fazzi, Lecce, Apulia, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Sensitivity (proportion) and agreement (Cohen K) of PET results (performed in different time points) compared to the current standard (TC plus bone marrow biopsy).

Time frame: 24 months

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.
C-index, estimated comparing models adding or not PET parameters to standard prognostic factors in predicting PFS.

Time frame: 24months

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.

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2025
First posted: Oct 23, 2020
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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