FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role
FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role
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.
A significant proportion of patients considered for this study will be retrieved from
 previous observational prospective clinical studies. Data on clinical presentation, treatment
 and follow-up will be obtained from the existing dataset of the previous protocols. For the
 additional cases identified from clinical practice data will be collected from patient chart.
 A unique study CRF will be prepared to collect all the required details.

 Patients with histologically confirmed marginal zone lymphomas according to the current WHO
 classification are registered in the study. Moreover, patients characteristics (PS, systemic
 symptoms), Ann Arbor stage, laboratory parameters, serology for hepatitis C, B and human
 immunodeficiency virus, bone marrow aspirate and biopsy data, data on treatment start and
 end, chemotherapy details, final response defined according to Cheson 2014 and Matutes
 criteria, date of last follow-up ,occurrence of any event (relapse, progression, death) with
 date will be collected.

 PET response will be initially coded according to local interpretation of scan report. All
 FDG-PET, will be then centralized to perform a blinded independent review of staging and
 response. Images will be centralized and examined by a panel of 3 nuclear medicine physicians
 that will independently review the scans. Each case will be evaluated by two reviewers. In
 case of discordant results a third reviewer will adjudicate the case.

 Each patient enrolled in the study will be anonymized by assigning a unique identification
 numerical code upon registration in the study. The unique identification code will be used to
 record health-related data.

 Anonymized PET data will be uploaded into the DICOM system by the responsible person of the
 site.

 Anonymized health-related data will be collected in the e-CRF. At each site, the responsible
 of the research or a delegated person will complete the e-CRF.

 Only the Study Chair and the Sponsor will have access rights for the health-related data and
 will be responsible for protection of the data.
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.