Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
zhang shoulong
50 participants
Mar 6, 2023
OBSERVATIONAL
Conditions
Summary
CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder. To test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.
Eligibility
Inclusion Criteria2
- Subjects must be ≥ 18 years of age at signing of informed consent.
- Subjects are scheduled to receive CAR T-cell treatment.
Exclusion Criteria8
- Refusal to sign the informed consent
- Subjects having previously been treated with CAR-T therapy.
- Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding
- Subjects presenting primary CNS lymphoma
- Pacemaker or other implanted electrical device incompatible with the MR environment
- Subjects with a neurodegenerative disease (PD, AD)
- Subjects with a previous or evolving neurological pathology
- Pregnant or breastfeeding women
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05643092