The Role of 18F-FDG-PET for Staging and Prognostication
1 other identifier
observational
200
2 countries
34
Brief Summary
A retrospective, multicenter, non-interventional, imaging study ancillary to FIL\_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2025
CompletedDecember 24, 2025
December 1, 2025
3 years
October 19, 2020
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Ematologia Ospedale Vito Fazzi
Lecce, Apulia, 73100, Italy
U.O.C Ematologia e Trapianto A.O. C. Panico
Tricase, Apulia, 73039, Italy
U.O.Ematologia Ospedale Guglielmo da Saliceto
Piacenza, Emilia-Romagna, 29121, Italy
Ematologia Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42123, Italy
U.O. di Ematologia Ospedale degli Infermi di Rimini
Rimini, Emilia-Romagna, 47923, Italy
S.O.C. Oncologia Medica A Centro Riferimento Oncologico
Aviano, Friuli Venezia Giulia, 33081, Italy
SOC Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine, Friuli Venezia Giulia, 33100, Italy
Ematologia Universitа Cattolica S. Cuore
Rome, Lazio, 00168, Italy
Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
Genoa, Liguria, 16132, Italy
U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
Genoa, Liguria, 16132, Italy
Ematologia ASST Spedali Civili di Brescia
Brescia, Lombardy, 25123, Italy
Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
Milan, Lombardy, 20122, Italy
SC Ematologia ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162, Italy
Ematologia ASST MONZA Ospedale S. Gerardo
Monza, Lombardy, 20900, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo di Pavia
Pavia, Lombardy, 27100, Italy
U.O. Ematologia Istituto Clinico Humanitas
Rozzano, Lombardy, 20089, Italy
Unità Linfomi - Dipartimento Oncoematologia - Istituto Scientifico San Raffaele
Milan, Milan, Italy
S.C. Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, 15121, Italy
S.C. di Ematologia e Trapianto di Midollo Osseo A.O. S. Croce e Carle
Cuneo, Piedmont, 12100, Italy
SCDU Ematologia AOU Maggiore della Caritа di Novara
Novara, Piedmont, 28100, Italy
Ematologia Universitaria A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126, Italy
S.C.Ematologia A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126, Italy
SC Ematologia e CTMO Ospedale Businco
Cagliari, Sardinia, 09121, Italy
S.C. Ematologia Azienda Ospedali Riuniti Papardo-Piemonte
Messina, Sicily, 98158, Italy
Divisione di Ematologia A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Sicily, 90146, Italy
Divisione di Ematologia e T.M.O. - Ospedale Centrale di Bolzano
Bolzano, Trentino-Alto Adige, 39100, Italy
Unitа funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141, Italy
S.C. Oncoematologia A.O. S. Maria di Terni
Terni, Umbria, 05100, Italy
S.C di Ematologia Ospedale Ca Foncello
Treviso, Veneto, 31100, Italy
U.O. Ematologia AOU Integrata di Verona
Verona, Veneto, 37134, Italy
Ematologia - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, 47014, Italy
U.O. Ematologia - AOU Pisana
Pisa, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
Trieste, Italy
Instituto Português de Oncologia de Lisboa
Lisbon, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Mian, MD
Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano, Italy
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
October 30, 2020
Primary Completion
October 26, 2023
Study Completion
July 11, 2025
Last Updated
December 24, 2025
Record last verified: 2025-12