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JOURNAL ONKOLOGIE – STUDIE
PIMENTO

FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role

Rekrutierend

NCT-Nummer:
NCT04333524

Studienbeginn:
Dezember 2020

Letztes Update:
08.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lymphoma, Lymphoma, B-Cell, Marginal Zone

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
International Extranodal Lymphoma Study Group (IELSG)

Collaborator:
-

Studienleiter

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

Kontakt

IELSG - Study Coordination Office
Kontakt:
Phone: +41 58 666 73
Phone (ext.): 21
E-Mail: ielsg@ior.usi.ch» Kontaktdaten anzeigen

Studienlocations
(3 von 25)

Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese
21100 Varese
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Michele Merli, MD
E-Mail: Michele.Merli@asst-settelaghi.it» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Correlation between CT and PET (Time Frame - At baseline):
To correlate CT and PET results for stage definition



Secondary outcome:

1. 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)

2. 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

Studien-Arme

  • Group A
    Staging
  • Group B
    Criteria for response assessment

Quelle: ClinicalTrials.gov


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