ctDNA-Guided Intraventricular Therapy for CNS Malignancies
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorAlireza Mansouri
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Diagnosis of histologically or cytologically confirmed HER2+ breast cancer, or triple negative breast cancer, or Stage IV non-small cell lung cancer, or recurrent high-grade glioma).
Undergoing clinically indicated cerebrospinal fluid (CSF) collection as part of routine clinical care: CSF may be obtained via lumbar puncture or existing CSF access device. Decision for CSF collection must be made independently by the treating clinical team and not solely for research purposes.
Detectable CSF ctDNA and/or positive CSF cytology, with consideration for CNS-directed management by the treating neuro-oncology team.
Disqualifiers
Age <18 years.
Inability to provide informed consent and no legally authorized representative (LAR) available.
Not undergoing clinically indicated CSF collection as part of standard clinical care.
Absence of detectable CSF ctDNA and absence of positive CSF cytology.
Trial design
Treatments tested in this trial
- CSF ctDNA-Guided Clinical Management
Treatment groups
77 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Alireza Mansouri
Lead sponsor
Milton S. Hershey Medical Center
Sponsor institution
Source ClinicalTrials.gov