Using imaging and blood tests to monitor CAR T-cell therapy in lymphoma patients
Radiomics and Metabolomics in the Follow-up of CAR T-cells for Refractory or Relapsed Non-Hodgkin's Lymphoma: Pilot Study
This study is testing if special imaging and blood tests can help doctors predict how well CAR T-cell therapy works for patients with tough-to-treat non-Hodgkin's lymphoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | CAR T |
| Locations | 1 site (Nice) |
| Trial ID | NCT05422521 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates whether radiomic signatures from 18FDG PET-CT scans and serum metabolomic profiles can serve as predictive or prognostic indicators for patients undergoing CAR T-cell therapy for refractory or relapsed non-Hodgkin's lymphoma. Patients will undergo imaging and blood tests at various intervals before and after treatment to assess their tumor response and monitor for potential side effects. The study aims to correlate these signatures with progression-free survival and clinical outcomes over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with refractory or relapsed non-Hodgkin's lymphoma who are eligible for CAR T-cell therapy.
Not a fit: Patients under 18 years old or those with contraindications to PET-CT scans will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to predict treatment responses and monitor side effects in lymphoma patients receiving CAR T-cell therapy.
How similar studies have performed: While the use of radiomics and metabolomics is gaining traction, this specific approach in the context of CAR T-cell therapy for lymphoma is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nice
- CHU de Nice — Nice, France (Recruiting)
Study contacts
- Principal investigator: Philippe VIAU — Centre Hospitalier Universitaire de Nice
- Study coordinator: Philippe VIAU, MD
- Email: viau.p@chu-nice.fr
- Phone: 0492035672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.