CompletedNot Applicable

The Role of 18F-FDG-PET for Staging and Prognostication

Italy, Portugal200 participantsStarted 2020-10-30

Plain-language summary

A retrospective, multicenter, non-interventional, imaging study ancillary to FIL\_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

C-index, estimated comparing models adding or not PET parameters to standard prognostic factors in predicting PFS.

Timeframe: 24months

Trial details

NCT IDNCT04600804

SponsorFondazione Italiana Linfomi - ETS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-26

View on ClinicalTrials.gov More Mantle Cell Lymphoma trials