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Clinical Trials in France / NCT04333524
Active, not recruiting Observational

FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role

NCT04333524 · tracked via the Priya Life Science France tracker
Sponsor
International Extranodal Lymphoma Study Group (IELSG)
Phase
Observational
Started
2020-12-01
Last updated
2026-07-24

Condition(s) studied

Marginal Zone Lymphoma

Study summary

The general aim of the present study is to assess the role of PET for the staging and for the assessment of response and outcome prediction in Marginal Zone Lymphoma (MZL). This study will be conducted as a multicenter retrospective analysis of MZL for whom PET scan are available as DICOM file for central review.

The study is designed as a retrospective collection of patients with MZL enrolled in the prospective IELSG36 and IELSG38 trials sponsored by IELSG and in the observational NF10 study sponsored by Federazione Italiana Linfomi (FIL), with the possibility to add additional cases from participating institutions.

The study will be conducted on performed scans. No additional scan or procedure will be required for study purposes.

The study will be divided into two sections with different aims:

Part A will be conducted to understand the role of PET for the staging of MZL. PET scans will be analyzed and compared with data retrieved from CT scan and from other staging procedures, also including bone marrow biopsy, ultrasound, and laboratory exams. This part of the study will describe ability of PET to identify pathologic lesions and to contribute to staging definition or to stage migration.

Part B will be conducted to validate standardized criteria for response assessment in MZL including FDG-PET among procedures and to define the prognostic role of metabolic response in MZL. For this purpose the primary endpoint for this part of the study is defined as the progression free survival. Secondary endpoint will be Overall survival, and response rate defined with conventional procedures and rate of histological transformation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. One of the following subtypes of Histology confirmed Indolent non-follicular B-cell lymphoma: * Splenic MZL (bone marrow histology and/or splenic tissue); * Extranodal MZL or MALT (tissue biopsy); * Nodal MZL (lymph node biopsy). 2. Age over 18. 3. Availability of details on clinical presentation, treatment details and results, and on follow-up. 4. Execution of PET at diagnosis or/and at end of treatment or/and at relapse. 5. Execution of CT scan with iodine contrast medium at diagnosis and at assessment of response. 6. Patients with histologically confirmed marginal zone lymphomas according to the current WHO classification are registered in the study. Diagnosis based on tru-cut core-needle biopsies are permitted in the study. 7. Written informed consent. Exclusion Criteria: 1. Patients with a diagnosis of Non Hodgkin Lymphoma other than MZL. 2. Scans images not available for whatever reason. 3. Cases diagnosed on fine needle aspiration cytology only.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
CHU de Dijon Dijon France
Saint Louis Hospital Paris France
IUCT Oncopole Toulouse Toulouse France
ASO SS. Antonio e Biagio e C. Arrigo Alessandria AL
Ospedale degli Infermi Ponderano BI
Ospedale Oncologico Businco Cagliari CA
"G. Rodolico", AOU Policlinico Vittorio Emanuele Catania CT
Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico Milan MI
Ospedale San Raffaele Milan MI
Fondazione IRCCS Istituto Nazionale dei Tumori Milan MI
AOU Policlinico "Paolo Giaccone" Palermo PA
I.R.C.C.S. Istituto Oncologico Veneto Padova PD
Ospedale Civile Spirito Santo Pescara Pescara PE
IRCCS Centro di Riferimento Oncologico di Aviano Aviano PN
Fondazione IRCCS Policlinico S. Matteo di Pavia Pavia PV
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo TO
A.O.U. Città della Salute e della Scienza di Torino Torino TO
A.O. Santa Maria di Terni Terni TR
Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese Varese VA
Policlinico GB Rossi Verona VR
IRCCS Istituto Tumori "Giovanni Paolo II" Bari Italy
AOU Federico II Naples Italy
AUSL IRCCS Reggio Emilia Reggio Emilia Italy
Hôpiteux Universitaires de Genève (HUG) Geneva Canton of Geneva
Istituto Oncologico della Svizzera Italiana Bellinzona Canton Ticino

More International Extranodal Lymphoma Study Group (IELSG) trials in France

Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients Active, not recruiting
Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma Active, not recruiting
Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma Recruiting
MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas Active, not recruiting
Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma Recruiting

Other trials for the same condition

A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma Recruiting
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. Active, not recruiting
A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies Recruiting
Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma Recruiting
MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04333524 on ClinicalTrials.gov ↗ ← All trials in France