Marginal Zone LymphomaPIMENTONCT04333524
FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role
An observational study of Marginal Zone Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 25 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma
- How many people
- 496 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 1 Dec 2020to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
- Age over 18.
- Availability of details on clinical presentation, treatment details and results, and on follow-up.
Show all 10Show fewer
- Execution of PET at diagnosis or/and at end of treatment or/and at relapse.
- Execution of CT scan with iodine contrast medium at diagnosis and at assessment of response.
- 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.
- Written informed consent.
Who cannot join
- Patients with a diagnosis of Non Hodgkin Lymphoma other than MZL.
- Scans images not available for whatever reason.
- Cases diagnosed on fine needle aspiration cytology only.
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
Italy20 sites
ASO SS. Antonio e Biagio e C. Arrigo
Alessandria, AL, 15121
IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, PN, 33081
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, 70124
Ospedale Oncologico Businco
Cagliari, CA, 09121
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, TO, 10060
"G. Rodolico", AOU Policlinico Vittorio Emanuele
Catania, CT, 95123
Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
Ospedale San Raffaele
Milan, MI, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, 20133
AOU Federico II
Naples, 80131
I.R.C.C.S. Istituto Oncologico Veneto
Padova, PD, 35128
AOU Policlinico "Paolo Giaccone"
Palermo, PA, 90144
Fondazione IRCCS Policlinico S. Matteo di Pavia
Pavia, PV, 27100
Ospedale Civile Spirito Santo Pescara
Pescara, PE, 65124
Ospedale degli Infermi
Ponderano, BI, 13875
AUSL IRCCS Reggio Emilia
Reggio Emilia, 42123
A.O. Santa Maria di Terni
Terni, TR, 05100
A.O.U. Città della Salute e della Scienza di Torino
Torino, TO, 10126
Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese
Varese, VA, 21100
Policlinico GB Rossi
Verona, VR, 37134
France3 sites
CHU de Dijon
Dijon, 21000
Saint Louis Hospital
Paris
IUCT Oncopole Toulouse
Toulouse, 31100
Switzerland2 sites
Istituto Oncologico della Svizzera Italiana
Bellinzona, Canton Ticino, 6500
Hôpiteux Universitaires de Genève (HUG)
Geneva, Canton of Geneva, 1205
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Marginal Zone Lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Staging | |
| Group B | Criteria for response assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between CT and PET
To correlate CT and PET results for stage definition
Measured: At baseline
Secondary outcomes (2)
Progression Free Survival (PFS)
Measured: 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)
DoR is evaluated only for responding patients
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Dec 2020
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Luminari, MD, Study chair, AUSL IRCCS - Reggio Emilia (Italy)Catherine Thieblemont, MD, Study chair, Saint-Louis Hospital, Paris, FranceEmanuele Zucca, MD, Study chair, Oncology Institute of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333524
- Sponsor's protocol ID
- IELSG44
- Acronym
- PIMENTO
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role: an International Multicenter Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04333524
- Acronym / sponsor ID
- PIMENTO / IELSG44
- Conditions
- Marginal Zone Lymphoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 496 participants (actual)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Staging |
| Group B | – | –Criteria for response assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- One of the following subtypes of Histology confirmed Indolent non-follicular B-cell lymphoma:
- Age over 18.
- Availability of details on clinical presentation, treatment details and results, and on follow-up.
- Execution of PET at diagnosis or/and at end of treatment or/and at relapse.
- Execution of CT scan with iodine contrast medium at diagnosis and at assessment of response.
Key exclusion criteria (3 listed)
- Patients with a diagnosis of Non Hodgkin Lymphoma other than MZL.
- Scans images not available for whatever reason.
- Cases diagnosed on fine needle aspiration cytology only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between CT and PET
Time frame: At baseline
To correlate CT and PET results for stage definition
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Luminari, MD study chair
AUSL IRCCS - Reggio Emilia (Italy)
Catherine Thieblemont, MD study chair
Saint-Louis Hospital, Paris, France
Emanuele Zucca, MD study chair
Oncology Institute of Southern Switzerland
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marginal Zone Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy, France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between CT and PET (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.