Clinical trial · Observational
The Role of 18F-FDG-PET for Staging and Prognostication
The Role of 18F-FDG-PET for Staging and Prognostication in Patients Enrolled in the Fondazione Italiana Linfomi (FIL) MCL0208 Trial
NCT04600804CI-TRIAL-00113177completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A retrospective, multicenter, non-interventional, imaging study ancillary to FIL\_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- All patients registered in the MCL0208 trial
- description
- About 200 patients enrolled in the MCL0208 trial who performed the PET exams within the clinical trial and who consent to the present study: all PETs available at each center participating in this study will be collected and analyzed. In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after- ASCT (eot-PET). All the PETs available per patient will be collected and considered for analysis, both in the case PET are available at all the 3 time points above listed and in case of availability of PET at 1 or 2 time points only.
Primary outcomes (2)
- measure
- Sensitivity (proportion) and agreement (Cohen K) of PET results (performed in different time points) compared to the current standard (TC plus bone marrow biopsy).
- timeFrame
- 24 months
- description
- To better define the role of PET for the staging of MCL patients at the time of diagnosis, for evaluation of response after induction treatment (pre-ASCT; i-PET) and post ASCT (eot-PET) in comparison to the current standards, namely computed axial tomography (CT) and bone marrow biopsy.
- measure
- C-index, estimated comparing models adding or not PET parameters to standard prognostic factors in predicting PFS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Enrollment of the patient in the MCL0208 clinical trial documented by the signature of the study informed consent; * Patient's treatment in one of the centers that participated in the MCL0208 trial and that has joined the MCL0208-PET study as well; * Evidence of signed informed consent for the MCL0208-PET study.
References
Publications (0)
Data not yet available
No reference posted for this study.