NCT07689721Not yet recruiting
ctDNA-Guided Intraventricular Therapy for CNS Malignancies
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
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 77 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 1 Jul 2030
- Lead sponsor
- Alireza Mansouri
- Diseases
- Lung cancer, Glioblastoma
- NCT number
- NCT07689721
What you commit to
- Study type: Interventional
- Planned participants: 77
- From 1 Jan 2027 to the primary completion date, 1 Jul 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinical contraindications to CSF collection, including but not limited to: Significant intracranial mass effect; (e.g., midline shift \>5 mm or effacement of basal cisterns); Obstructive hydrocephalus or posterior fossa mass effect; Coagulopathy or bleeding risk precluding lumbar puncture or CSF access; Inability to safely obtain CSF access.
Age
- Age \<18 years.
Other
- 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.
- Not being considered for CNS-directed management by the treating neuro-oncology team.
Who the study is looking for
- 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.
- Ability to provide informed consent, or availability of a legally authorized representative (LAR).
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.