Clinical trial · Interventional
Magnetic Resonance Imaging in Immune Effector Cell-Associated Neurotoxicity Syndrome
Contribution of Magnetic Resonance Imaging in Immune Effector Cell-Associated Neurotoxicity Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The treatment of large-cell B-cell lymphomas refractory to more than 2 lines of therapy has recently been revolutionized by the use of immunotherapies consisting of autologous genetically modified cells or CAR-T CELLS (chimeric antigen receptor-T cells), which very significantly increase progression-free survival and overall survival. Nevertheless, this therapy is frequently associated with cytokine release syndrome and in approximately 20% to 60% of patients with neurological complications that can sometimes be dramatic and are associated with a significant mortality rate. The mechanisms behind this neurotoxicity are unclear. Despite the frequent occurrence of neurological toxicity characterized in particular by headache, tremor, and encephalopathy that is most often transient, brain imaging by CT or, preferably, MRI are most often normal. The rare abnormalities that have been identified suggest the presence of cytotoxic edema associated with the existence of transient modifications of the blood-brain barrier. To date, the management of neurotoxicity associated with CAR-T CELLS remains empirical. It combines early management of cytokine release syndrome (by administration of anti-IL6) and treatment with corticosteroids, the objective of which would be to control neurotoxicity more specifically. A better understanding of the pathophysiological mechanisms associated with this neurotoxicity appears essential today in order to be able to propose adapted prevention and treatment methods. Main objectives are to compare tissue permeability by quantitative MRI measurement of Ktrans to the theoretical peak of neurotoxicity between patients with CAR-T Cell-induced neurotoxicity and those without neurotoxicity and to Study, by MRI, the evolution of tissue microcirculatory parameters (from D-3 to D7) between groups of patients with or without the occurrence of neurotoxicity associated with CAR-T CELL treatment. For this purpose, 25 subjects will be included (the investigators hypothesize 40% with treatment-induced neurological impairment).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood withdrawal | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging with contrast injection | Other | — | UNRESOLVED |
| Neuropsychological tests | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients with CAR-T Cell treatment
- description
- Single arm All patient will undergo an MRI with contrast injection, a blood withdrawal and a neurological consultation with neuropsychological tests
- interventionNames
- Other: Magnetic Resonance Imaging with contrast injection
- Other: Blood withdrawal
- Other: Neuropsychological tests
Primary outcomes (1)
- measure
- Study of tissue permeability evolution
- timeFrame
- 10 days
- description
- Quantitative measurement of KTRANS (rate of contrast agent transfer from plasma to the extravascular extracellular space, reflecting capillary permeability). (Time in second)
Secondary outcomes (16)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject aged from 18 years old * Subject able to understand the nature, purpose and methodology of the study * Subject with diffuse large B-cell lymphoma to be treated with axicabtagene ciloleucel, tisagenlecleucel or brexucabtagene autoleucel for their lymphoma. Exclusion Criteria: * Refusal to sign the informed consent * Subject presenting a cerebral localization of his lymphoma * Contraindication to the realization of an MRI (metallic foreign body, pace-maker, cochlear implants) * Claustrophobic subject * Subject with a neurodegenerative disease (Parkinson's, Alzheimer's...) * Subject with psychiatric disorders such as psychosis, except for anxiety-depressive episodes * Subject with a systemic pathology with neurological manifestation * Subject with a previous or evolving neurological pathology * Subject with or with a history of severe head trauma (group 2 or 3 according to the Masters classification) * Contraindication to the use of gadoline contrast products (severe renal insufficiency, liver transplantation, known or suspected hypersensitivity to the product) * Pregnant or breastfeeding women * Patient under tutelage * Patient under curatorship * Patient deprived of liberty * Not a beneficiary of a social security system
References
Publications (0)
Data not yet available