The Role of 18F-FDG-PET for Staging and Prognostication
- Conditions
- Mantle Cell Lymphoma
- Registration Number
- NCT04600804
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
U.O.Ematologia Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Emilia Romagna, Italy
Ematologia Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Emilia Romagna, Italy
U.O. di Ematologia Ospedale degli Infermi di Rimini
🇮🇹Rimini, Emilia Romagna, Italy
S.O.C. Oncologia Medica A Centro Riferimento Oncologico
🇮🇹Aviano, Friuli Venezia Giulia, Italy
SOC Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
🇮🇹Udine, Friuli Venezia Giulia, Italy
Ematologia Universitа Cattolica S. Cuore
🇮🇹Roma, Latium, Italy
Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
🇮🇹Genova, Liguria, Italy
U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
🇮🇹Genova, Liguria, Italy
Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
🇮🇹Milano, Lombardia, Italy
SC Ematologia ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Lombardia, Italy
Scroll for more (24 remaining)U.O.Ematologia Ospedale Guglielmo da Saliceto🇮🇹Piacenza, Emilia Romagna, Italy