FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role (PIMENTO)

July 23, 2026 updated by: International Extranodal Lymphoma Study Group (IELSG)

FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role: an International Multicenter Retrospective Analysis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
496

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: IELSG - Study Coordination Office
  • Phone Number: 21 +41 58 666 73
  • Email: ielsg@ior.usi.ch

Study Locations

  • France
      • Dijon, France, 21000
        • CHU de Dijon
      • Paris, France
        • Saint Louis Hospital
      • Toulouse, France, 31100
        • IUCT Oncopole Toulouse
  • Italy
      • Bari, Italy, 70124
        • IRCCS Istituto Tumori "Giovanni Paolo II"
      • Naples, Italy, 80131
        • AOU Federico II
      • Reggio Emilia, Italy, 42123
        • AUSL IRCCS Reggio Emilia
    • AL
      • Alessandria, AL, Italy, 15121
        • ASO SS. Antonio e Biagio e C. Arrigo
    • BI
      • Ponderano, BI, Italy, 13875
        • Ospedale degli Infermi
    • CA
      • Cagliari, CA, Italy, 09121
        • Ospedale Oncologico Businco
    • CT
      • Catania, CT, Italy, 95123
        • "G. Rodolico", AOU Policlinico Vittorio Emanuele
    • MI
      • Milan, MI, Italy, 20132
        • Ospedale San Raffaele
      • Milan, MI, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, MI, Italy, 20122
        • Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico
    • PA
      • Palermo, PA, Italy, 90144
        • AOU Policlinico "Paolo Giaccone"
    • PD
      • Padova, PD, Italy, 35128
        • I.R.C.C.S. Istituto Oncologico Veneto
    • PE
      • Pescara, PE, Italy, 65124
        • Ospedale Civile Spirito Santo Pescara
    • PN
      • Aviano, PN, Italy, 33081
        • IRCCS Centro di Riferimento Oncologico di Aviano
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione IRCCS Policlinico S. Matteo di Pavia
    • TO
      • Candiolo, TO, Italy, 10060
        • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
      • Torino, TO, Italy, 10126
        • A.O.U. Citta della Salute e della Scienza di Torino
    • TR
      • Terni, TR, Italy, 05100
        • A.O. Santa Maria di Terni
    • VA
      • Varese, VA, Italy, 21100
        • Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese
    • VR
      • Verona, VR, Italy, 37134
        • Policlinico GB Rossi
  • Switzerland
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • Istituto Oncologico della Svizzera Italiana
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1205
        • Hôpiteux Universitaires de Genève (HUG)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with MZL enrolled in the prospective IELSG36 and IELSG38 trials and on the observational NF10, with the possibility to add additional cases from participating institutions

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group A
Staging
Group B
Criteria for response assessment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation between CT and PET
Time Frame: At baseline
To correlate CT and PET results for stage definition
At baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From date of enrollment until the date of first documented progression, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years
From date of enrollment until the date of first documented progression, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years
Duration of Response (DoR)
Time Frame: From date of first response to the date of relapse, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years
DoR is evaluated only for responding patients
From date of first response to the date of relapse, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Extranodal Lymphoma Study Group (IELSG)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Catherine Thieblemont, MD, Saint-Louis Hospital, Paris, France
  • Study Chair: Stefano Luminari, MD, AUSL IRCCS - Reggio Emilia (Italy)
  • Study Chair: Emanuele Zucca, MD, Oncology Institute of Southern Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IELSG44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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