The Role of 18F-FDG-PET for Staging and Prognostication
NCT ID: NCT04600804
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2020-10-30
2025-07-11
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Michael Mian, MD
Role: PRINCIPAL_INVESTIGATOR
Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano, Italy
Locations
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Ematologia Ospedale Vito Fazzi
Lecce, Apulia, Italy
U.O.C Ematologia e Trapianto A.O. C. Panico
Tricase, Apulia, Italy
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
Rome, Lazio, Italy
Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
Genoa, Liguria, Italy
U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
Genoa, Liguria, Italy
Ematologia ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
Milan, Lombardy, Italy
SC Ematologia ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Ematologia ASST MONZA Ospedale S. Gerardo
Monza, Lombardy, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo di Pavia
Pavia, Lombardy, Italy
U.O. Ematologia Istituto Clinico Humanitas
Rozzano, Lombardy, 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, Italy
S.C. di Ematologia e Trapianto di Midollo Osseo A.O. S. Croce e Carle
Cuneo, Piedmont, Italy
SCDU Ematologia AOU Maggiore della Caritа di Novara
Novara, Piedmont, Italy
Ematologia Universitaria A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy
S.C.Ematologia A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy
SC Ematologia e CTMO Ospedale Businco
Cagliari, Sardinia, Italy
S.C. Ematologia Azienda Ospedali Riuniti Papardo-Piemonte
Messina, Sicily, Italy
Divisione di Ematologia A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Sicily, Italy
Divisione di Ematologia e T.M.O. - Ospedale Centrale di Bolzano
Bolzano, Trentino-Alto Adige, Italy
Unitа funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
S.C. Oncoematologia A.O. S. Maria di Terni
Terni, Umbria, Italy
S.C di Ematologia Ospedale Ca Foncello
Treviso, Veneto, Italy
U.O. Ematologia AOU Integrata di Verona
Verona, Veneto, Italy
Ematologia - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, , Italy
U.O. Ematologia - AOU Pisana
Pisa, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
Trieste, , Italy
Instituto Português de Oncologia de Lisboa
Lisbon, , Portugal
Countries
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Other Identifiers
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FIL_MCL0208-PET
Identifier Type: -
Identifier Source: org_study_id