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NOT YET RECRUITING
NCT07689721
NA

ctDNA-Guided Intraventricular Therapy for CNS Malignancies

Sponsor: Alireza Mansouri

View on ClinicalTrials.gov

Summary

This prospective, single-center study will evaluate whether cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) testing using the Belay Summit assay can improve the clinical management of patients with malignant gliomas or brain metastases from non-small cell lung cancer (NSCLC) or breast cancer who are suspected of having central nervous system (CNS) disease. Patients undergoing clinically indicated CSF evaluation will receive standard clinical testing, including CSF cytology and the Belay Summit ctDNA assay. Treatment decisions will remain at the discretion of the treating multidisciplinary neuro-oncology team. The primary objective is to evaluate 6-month clinical CNS progression-free survival (cCNS-PFS), with secondary objectives assessing safety and the association between CSF ctDNA dynamics and clinical outcomes. Exploratory proteogenomic analyses will be performed on residual CSF specimens when sufficient sample is available.

Official title: ctDNA-Guided Intraventricular Therapy Trial: A Prospective Study in Patients With Malignant Gliomas or Brain Metastases From Non-Small Cell Lung Cancer and Breast Cancer

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

77

Start Date

2027-01-01

Completion Date

2032-01-01

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DEVICE

CSF ctDNA-Guided Clinical Management

Participants undergo clinically indicated cerebrospinal fluid (CSF) evaluation, including CSF cytology and the Belay Summit CSF circulating tumor DNA (ctDNA) assay. Results are incorporated into multidisciplinary neuro-oncology evaluation to inform CNS-directed clinical management. Treatment decisions, including intraventricular therapy, systemic therapy modification, radiation therapy, or other interventions, remain at the discretion of the treating physicians and are not mandated by the study protocol. The primary objective is to evaluate cCNS-PFS at 6 months. Secondary objectives include evaluating the safety of CNS-directed management and assessing the relationship between longitudinal CSF ctDNA dynamics and clinical outcomes.