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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04600804

Enrollment

200

Registered

2020-10-23

Start date

2020-10-30

Completion date

2025-07-11

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma

Keywords

prognostic issues, PET review, MCL

Brief summary

A retrospective, multicenter, non-interventional, imaging study ancillary to FIL\_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.

Detailed 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Italy, Portugal

Contacts

PRINCIPAL_INVESTIGATORMichael Mian, MD

Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano, Italy

Outcome results