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

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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Italy
  • Meldola, Italy, 47014
    • Ematologia - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
  • Pisa, Italy
    • U.O. Ematologia - AOU Pisana
  • Trieste, Italy
    • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
  • Apulia
    • Lecce, Apulia, Italy, 73100
      • Ematologia Ospedale Vito Fazzi
    • Tricase, Apulia, Italy, 73039
      • U.O.C Ematologia e Trapianto A.O. C. Panico
  • Emilia-Romagna
    • Piacenza, Emilia-Romagna, Italy, 29121
      • U.O.Ematologia Ospedale Guglielmo da Saliceto
    • Reggio Emilia, Emilia-Romagna, Italy, 42123
      • Ematologia Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
    • Rimini, Emilia-Romagna, Italy, 47923
      • U.O. di Ematologia Ospedale degli Infermi di Rimini
  • Friuli Venezia Giulia
    • Aviano, Friuli Venezia Giulia, Italy, 33081
      • S.O.C. Oncologia Medica A Centro Riferimento Oncologico
    • Udine, Friuli Venezia Giulia, Italy, 33100
      • SOC Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Ematologia Universitа Cattolica S. Cuore
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
    • Genoa, Liguria, Italy, 16132
      • U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • Ematologia ASST Spedali Civili di Brescia
    • Milan, Lombardy, Italy, 20122
      • Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
    • Milan, Lombardy, Italy, 20162
      • SC Ematologia ASST Grande Ospedale Metropolitano Niguarda
    • Monza, Lombardy, Italy, 20900
      • Ematologia ASST MONZA Ospedale S. Gerardo
    • Pavia, Lombardy, Italy, 27100
      • Div. di Ematologia IRCCS Policlinico S. Matteo di Pavia
    • Rozzano, Lombardy, Italy, 20089
      • U.O. Ematologia Istituto Clinico Humanitas
  • Milan
    • Milan, Milan, Italy
      • Unità Linfomi - Dipartimento Oncoematologia - Istituto Scientifico San Raffaele
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • S.C. Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo
    • Cuneo, Piedmont, Italy, 12100
      • S.C. di Ematologia e Trapianto di Midollo Osseo A.O. S. Croce e Carle
    • Novara, Piedmont, Italy, 28100
      • SCDU Ematologia AOU Maggiore della Caritа di Novara
    • Turin, Piedmont, Italy, 10126
      • Ematologia Universitaria A.O.U. Citta della Salute e della Scienza di Torino
    • Turin, Piedmont, Italy, 10126
      • S.C.Ematologia A.O.U. Citta della Salute e della Scienza di Torino
  • Sardinia
    • Cagliari, Sardinia, Italy, 09121
      • SC Ematologia e CTMO Ospedale Businco
  • Sicily
    • Messina, Sicily, Italy, 98158
      • S.C. Ematologia Azienda Ospedali Riuniti Papardo-Piemonte
    • Palermo, Sicily, Italy, 90146
      • Divisione di Ematologia A.O. Ospedali Riuniti Villa Sofia-Cervello
  • Trentino-Alto Adige
    • Bolzano, Trentino-Alto Adige, Italy, 39100
      • Divisione di Ematologia e T.M.O. - Ospedale Centrale di Bolzano
  • Tuscany
    • Florence, Tuscany, Italy, 50141
      • Unitа funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi
  • Umbria
    • Terni, Umbria, Italy, 05100
      • S.C. Oncoematologia A.O. S. Maria di Terni
  • Veneto
    • Treviso, Veneto, Italy, 31100
      • S.C di Ematologia Ospedale Ca Foncello
    • Verona, Veneto, Italy, 37134
      • U.O. Ematologia AOU Integrata di Verona
• Portugal
  • Lisbon, Portugal
    • Instituto Português de Oncologia de Lisboa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A total of 300 patients have been enrolled in the MCL0208 trial. We expect to analyze the PETs, clinical and biological data of 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

All patients registered in the MCL0208 trial; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity (proportion) and agreement (Cohen K) of PET results (performed in different time points) compared to the current standard (TC plus bone marrow biopsy).	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.	24 months
C-index, estimated comparing models adding or not PET parameters to standard prognostic factors in predicting PFS.	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.	24months

Collaborators and Investigators

• Sponsor: Fondazione Italiana Linfomi - ETS
• Investigators: Principal Investigator: Michael Mian, MD, Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano, Italy

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: MCL; prognostic issues; PET review
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Mantle-Cell
• Other Study ID Numbers: FIL_MCL0208-PET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No