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FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role

Study acronym: PIMENTO
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 24, 2026 (before its estimated October 15, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 15, 2026 → Oct 15, 2026
See other at-risk trials from International Extranodal Lymphoma Study Group (IELSG)

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary and study completion pushed from Jun 15, 2026 to Oct 15, 2026v12
  2. Notable Primary and study completion dates: Dec 15, 2025 to Jun 15, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 350 to confirmed 496
    • Site details revised at 25 of 25 sites
    v11
  3. Notable Primary and study completion dates: Jan 15, 2024 to Dec 15, 2025v10
  4. Notable Primary and study completion dates: Jun 15, 2023 to Jan 15, 2024
    • Study sites: 23 to 25
    v9
  5. Minor Primary completion date: Feb 15, 2023 to Jun 15, 2023v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv7
  2. Minor Site contacts updated at 1 of 23 sitesv6
  3. Notable Primary endpoints: 3 to 1
    • Secondary endpoints expanded, about 8 words
    • Site details revised at 2 of 23 sites
    v5
  4. Minor Study sites: 17 to 23v4
  5. Minor Study sites: 16 to 17v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 16
    • Start date changed from estimate of Sep 15, 2020 to Dec 1, 2020
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04333524
Lead Sponsor International Extranodal Lymphoma Study Group (IELSG)
Conditions
(from sponsor)
Marginal Zone Lymphoma
Related terms Lymphoma, B-Cell, Marginal Zone
Enrollment 496 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov