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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
* 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)
CHU de Nice
Nice, France
RECRUITINGProgression-free survival (PFS) compared and correlated with signatures of the radiomics and serum metabolomics index
Progression-free survival (PFS)
Time frame: 7 days, 1 month, 3 months, 6 months, 9 months and 12 months post treatment.
Occurrence of severe side effects compared and correlated with the signatures of the radiomics and serum metabolomics indexes.
occurrence of severe side effects
Time frame: 7 days, 1 month, 3 months, 6 months, 9 months and 12 months after injection
Mickael LOSCHI, MD
CONTACT
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