Skip to main content
OpenTrials
Completed

NCT Number: NCT05422521

Radiomics and Metabolomics in the Follow-up of CAR T-cells for Refractory or Relapsed Non-Hodgkin's Lymphoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06000, France

About this study

In this study the search for relevant radiomic signature will be carried out for each patient benefiting from an 18FDG PET-CT during the pre-treatment assessment and then in the follow-up at 1 month, 3 months, 6 months, 9 months and 12 months post treatment.

The search for circulating metabolites in serum (mass spectrometry) will be carried out during the pre-therapeutic assessment, then in the follow-up at 7 days, 1 month, 3 months, 6 months, 9 months and 12 months post treatment.

The main objective of the study is the comparison of signatures from radiomics and early serum metabolomic indices according to progression-free survival at 12 months of patients treated with CAR T-cells for refractory or relapsed non-Hodgkin's lymphoma, in correlation with clinical and biological monitoring, to predict tumor response.

The secondary objective is the comparison of the signatures of early serum radiomic and metabolic indices according to the occurrence of serious clinical and/or biological side effects in the 12 months following treatment with CAR T cells.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples and 18FDG PET-CT exams

Other
  • 18 FDG PET scanner at inclusion and post CART-cells treatment ( 1, 3, 6, 9 and 12 month)
  • blood collection at inclusion and post CART-cells treatment (7 days, 1 month and 3 month)

Primary outcomes

  1. Progression-free survival (PFS) compared and correlated with signatures of the radiomics and serum metabolomics index

    Time frame: 7 days, 1 month, 3 months, 6 months, 9 months and 12 months post treatment.

    Progression-free survival (PFS)

Secondary outcomes

  1. Occurrence of severe side effects compared and correlated with the signatures of the radiomics and serum metabolomics indexes.

    Time frame: 7 days, 1 month, 3 months, 6 months, 9 months and 12 months after injection

    occurrence of severe side effects

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Radiomics and Metabolomics in the Follow-up of CAR T-cells for Refractory or Relapsed Non-Hodgkin's Lymphoma: Pilot Study

Acronym: CART-Omic

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 16, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.