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Lumbar Punctures for Detecting ctDNA in Lung Cancer

This study is looking at whether a procedure called a lumbar puncture (spinal tap) can help detect circulating tumor DNA (ctDNA) in the fluid around your brain and spinal cord (cerebrospinal fluid or CSF). This is for patients with Stage III and IV non-small cell lung cancer (NSCLC). Doctors want to see if finding ctDNA in the CSF can predict if the cancer will spread to the brain. They also want to confirm that ctDNA can be found in the CSF of patients whose lung cancer has already spread to the brain. This study involves collecting blood samples, undergoing a lumbar puncture, and having an MRI. You might be able to join if you have a new diagnosis of Stage III or IV NSCLC, have certain genetic mutations if your cancer hasn't spread to the brain, and are receiving treatment at Ohio State University. The study aims to see how many patients with locally advanced lung cancer develop brain disease within 6 months and the rate of ctDNA detection in CSF for those with brain metastases within 12 months. The current recruitment status is unclear.

Study design
This is an interventional study with 40 planned participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo a lumbar puncture, blood sample collection, and MRI scans. The timing of these procedures depends on whether your cancer has spread to the brain.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months, with the primary outcomes measured at up to 6 months and up to 12 months.

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NCT06816979

Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer

Not Yet Recruiting
NAAll AgesInterventionalScreening
Ohio State University Comprehensive Cancer Center
~40 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Biospecimen CollectionLumbar PunctureMagnetic Resonance Imaging

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects with Intracranial disease in locally advanced lung cancer patients
Measured over Up to 6 months
+1 more outcome measured

Conditions

Lung Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8

Explore related trials

Lung Non-Small Cell CarcinomaPULMOL

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Joshua D Palmer, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State Comprehensive Cancer Center
[email protected]
800-293-5066
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

New histological diagnosis of stage III or IV NSCLC
For stage III/IV NSCLC patients without brain metastases, a documented mutation on lung cancer mutation panel (PULMOL) is required
Patient treated with radiation therapy and/or systemic therapy at Ohio State University
Estimated survival \>= 1 year
No medical contraindication to lumbar puncture

Exclusion

Patient has Alzheimer's, dementia, or mental disability
Patient is not able to receive MRI
Patient has allergy to xylocaine or any numbing medication for lumbar puncture
Previous cancer history prior to diagnosis of NSCLC
Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the medication and radiation required for standard of care treatment has unknown effects on the unborn fetus

What this trial measures

  • Number of subjects with Intracranial disease in locally advanced lung cancer patientsUp to 6 months

    An MRI will be performed six months after lumbar puncture in Cohort One. MRI sequences with T1 post-contrast for disease and structure definition and T2/FLAIR sequences for identification of peri-tumoral edema or cystic volumes will be obtained.

  • Cerebral spinal fluid- circulating tumor deoxyribonucleic acid (ctDNA) detection rate for lung non-small cell carcinoma patients with metastatic disease to the brainUp to 12 months

    Will estimate the frequency of ctDNA detection with a 90% Clopper-Pearson confidence interval.