About this trial
This phase I trial assesses the use of lumbar punctures to detect whether there is circulating tumor deoxyribonucleic acid (ctDNA) in the fluid that surrounds the brain and spinal cord (cerebrospinal fluid) in patients with stage III and IV non-small cell lung cancer (NSCLC). Patients with stage III and IV NSCLC are at risk of having their cancer spread from where it first started to the brain (metastatic). Because of this, more effective prognostic tools are necessary to determine which stage III and IV NSCLC patients are more likely to develop brain metastases. Cerebrospinal fluid (CSF) could be a reliable source of ctDNA to confirm and predict the presence of brain metastases in these patients. Assessing cell free DNA shed from tumor cells could be a sensitive and minimally invasive way to detect or characterize metastatic tumors in the central nervous system (CNS). Lumbar puncture is procedure in which a thin needle called a spinal needle is put into the lower part of the spinal column to collect CSF. Lumbar punctures for the collection of CSF may help doctors detect or measure changes in cell types, genes, and proteins of circulating tumor cells related to lung cancer that will help determine the presence of brain metastases which could become a standard of care screening tool utilized in the follow-up of patients diagnosed with stage II or IV NSCLC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Lumbar Puncture
Procedure/SurgeryUndergo LP
Magnetic Resonance Imaging
DeviceUndergo MRI
Treatment groups
Trial outcomes
Primary outcomes
Number of subjects with Intracranial disease in locally advanced lung cancer patients
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 brain
Will estimate the frequency of ctDNA detection with a 90% Clopper-Pearson confidence interval.
Sponsors and contacts
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