Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 5:36 PM
Study NCT ID:
NCT04600804
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of 18F-FDG-PET for Staging and Prognostication
Sponsor:
Fondazione Italiana Linfomi - ETS
Organization:
Study Overview
Official Title:
The Role of 18F-FDG-PET for Staging and Prognostication in Patients Enrolled in the Fondazione Italiana Linfomi (FIL) MCL0208 Trial
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A retrospective, multicenter, non-interventional, imaging study ancillary to FIL\_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.
Detailed Description:
This is a retrospective, multicenter, non-interventional, imaging study devoted to patients diagnosed with MCL and enrolled in the MCL0208 international randomized, phase III clinical trial (NCT02354313).
The study is aimed at addressing a number of prognostic issues that still need to be clarified in MCL patients, by taking advantage of the PET performed within the MCL0208 trial and available for the analysis, and the clinical records and molecular data generated in the context of the trial.
In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after-ASCT (eot-PET), and none of the exams was used in the decisionmaking strategy. All the PETs available will be collected and considered for analysis. The study will not require additional treatment or procedures except those required for the MCL0208 trial. The participation of the patient to the MCL0208 trial is a pre-requisite to be involved in this study.
The study is aimed at addressing a number of prognostic issues that still need to be clarified in MCL patients, by taking advantage of the PET performed within the MCL0208 trial and available for the analysis, and the clinical records and molecular data generated in the context of the trial.
In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after-ASCT (eot-PET), and none of the exams was used in the decisionmaking strategy. All the PETs available will be collected and considered for analysis. The study will not require additional treatment or procedures except those required for the MCL0208 trial. The participation of the patient to the MCL0208 trial is a pre-requisite to be involved in this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: