Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT05643092

Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome

Led by zhang shoulong · Updated on 2023-03-07

50

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

Sponsors

Z

zhang shoulong

Lead Sponsor

J

Jinan Military General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must be 18 years of age or older at signing of informed consent
  • Subjects are scheduled to receive CAR T-cell treatment
Not Eligible

You will not qualify if you...

  • 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 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 such as Parkinson's disease or Alzheimer's disease
  • Subjects with previous or evolving neurological pathology
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

980th Hospital

Shijiazhuang, Hebei, China

Actively Recruiting

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Research Team

S

Shoulong Zhang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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