Radiomics and Metabolomics in the Follow-up of CAR T-cells for Refractory or Relapsed Non-Hodgkin… (NCT05422521) | Clinical Trial Compass
CompletedNot Applicable
Radiomics and Metabolomics in the Follow-up of CAR T-cells for Refractory or Relapsed Non-Hodgkin's Lymphoma
France20 participantsStarted 2022-08-29
Plain-language summary
This is an interventionnal pilot study to investigate whether 18FDG radiomics or serum metabolomic signatures could be predictive or prognostic factors in the follow-up of patients receiving CAR T-cell therapy for refractory non-Hodgkin's lymphoma or in relapse.
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:
* Age greater than or equal to 18 years old
* Patients with histologically proven, refractory or relapsed, non-Hodgkin's lymphoma as indicated for CAR T-cell therapy
* ECOG score 0 to 2
* Affiliated patient or beneficiary of a social security scheme
* Patient having signed prior informed consent.
Exclusion Criteria:
* Be under 18 years old,
* Contraindication to performing 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes during PET-CT examinations (young capillary blood sugar ≥ 11 mmol),
* Any participation in other biomedical studies relating to drugs, medical devices or imaging techniques is prohibited, with the exception of so-called non-health product biomedical studies.
* Hypersensitivity to the active substance or to any of the excipients in the composition of CAR T-cells preparations
* Pregnant or breastfeeding women
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.
1Since this trial has already completed and was focused on using imaging and blood-based markers to track how well CAR T-cell therapy is working, can you tell me if the findings from this study might influence how my own response to CAR T-cell treatment would be monitored?
2This trial was measuring something called radiomics and metabolomics — can you explain in plain terms what those are, and whether our hospital currently uses these kinds of tools to follow patients after CAR T-cell therapy for relapsed or refractory Non-Hodgkin's Lymphoma?
3The trial tracked progression-free survival and tried to connect it to patterns in scans and blood samples — does that mean the goal was to find earlier warning signs that the lymphoma is coming back, and is that kind of monitoring available to me outside of a clinical trial?
4Since this was an observational study rather than a treatment trial, does it change the conversation about what my standard CAR T-cell treatment plan would look like, and are there other active trials testing actual new treatments I should also be considering?
5Given that this trial is now completed, is there a way to find out what the results showed, and could those results affect the follow-up schedule or the specific tests my care team would use to watch for relapse after CAR T-cell therapy?
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
1
Progression-free survival (PFS) compared and correlated with signatures of the radiomics and serum metabolomics index
Timeframe: 7 days, 1 month, 3 months, 6 months, 9 months and 12 months post treatment.