Lumbar Punctures for Lung Cancer

Overseen By The Ohio State Comprehensive Cancer Center

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Alzheimer's, Dementia, Mental disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a lumbar puncture (a test that collects fluid from the spine) can detect DNA from lung cancer cells in the fluid around the brain and spine. It focuses on patients with advanced non-small cell lung cancer (NSCLC) to determine if the cancer might spread to the brain. Individuals recently diagnosed with stage III or IV NSCLC and receiving treatment at Ohio State University may be suitable candidates. Detecting cancer DNA in this fluid could help predict brain cancer spread, potentially improving patient care. As an unphased study, this trial offers patients the chance to contribute to groundbreaking research that could enhance future diagnostic methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that lumbar punctures are safe for detecting ctDNA in cerebrospinal fluid?

Previous research has shown that lumbar punctures are safe for cancer patients. A lumbar puncture involves using a thin needle to collect fluid from the lower spine. Doctors test this fluid for tumor DNA to determine if cancer has spread to the brain.

Studies have demonstrated that using imaging techniques to guide the procedure makes lumbar punctures both safe and effective for fluid collection. No major safety concerns have been reported, and patients generally tolerate the procedure well. This indicates that the risks are low, making it a reliable method for gathering important information about cancer progression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using lumbar punctures for lung cancer patients because this technique offers a unique way to detect cancer-related DNA in cerebrospinal fluid (CSF). Unlike traditional treatments that focus on directly targeting tumors with drugs or radiation, this method helps monitor the presence of circulating tumor DNA (ctDNA) in the CSF, potentially providing early insights into disease progression or response to treatment. By identifying ctDNA early, doctors can make more informed decisions about treatment strategies, especially for patients with advanced stages of lung cancer. This approach could lead to more personalized and timely interventions, enhancing patient outcomes.

What evidence suggests that lumbar punctures are effective for detecting ctDNA in NSCLC patients?

Research has shown that lumbar punctures can detect tumor DNA in the cerebrospinal fluid (CSF) of patients with advanced lung cancer. In this trial, participants in Cohort 1, with stage III/IV lung cancer without brain metastases, and participants in Cohort 2, with stage IV NSCLC with brain metastases, will undergo lumbar punctures for CSF collection. Studies have found that circulating tumor DNA (ctDNA) in the CSF can indicate the spread of cancer to the brain, known as brain metastases. One study identified genetic changes linked to the spread of lung cancer by examining CSF from lumbar punctures. This method is considered sensitive and less invasive for assessing whether cancer has reached the central nervous system. Detecting ctDNA in the CSF may help doctors predict which patients are more likely to develop brain metastases. ^{1 3 6 7 8}

Who Is on the Research Team?

Joshua D Palmer, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with advanced non-small cell lung cancer (stages III and IV). It's designed to see if a procedure called lumbar puncture can detect tumor DNA in spinal fluid, which might help predict brain metastases. Participants should be at risk of their cancer spreading to the brain.

Inclusion Criteria

Estimated survival >= 1 year

My lung cancer is at an advanced stage (III or IV).

My advanced lung cancer has a specific mutation identified by a test.

Exclusion Criteria

Previous cancer history prior to diagnosis of NSCLC

Patient has Alzheimer's, dementia, or mental disability

I cannot undergo an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients undergo lumbar puncture for collection of CSF and blood sample collection, and MRI during screening

1-2 weeks

1 visit (in-person)

Follow-up

Patients are monitored for ctDNA presence and undergo additional lumbar puncture if necessary; MRI performed at 6 months for Cohort 1

6-12 months

2-3 visits (in-person)

Long-term follow-up

Patients without brain metastases are followed for 12 months, while those with brain metastases are followed for 6 months

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Lumbar Puncture

Trial Overview The study is testing whether lumbar punctures can find circulating tumor DNA in cerebrospinal fluid as a way to foresee brain metastasis in stage III and IV NSCLC patients. The trial includes MRI scans and biospecimen collection for analysis.

How Is the Trial Designed?

Group I: Cohort 2: Stage IV NSCLC with brain metastases (LP) Experimental Treatment 3 Interventions

Patients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening. Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.

Group II: Cohort 1: Stage III/IV without brain metastases (LP) Experimental Treatment 3 Interventions

Patients undergo LP for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo MRI during screening and 12 month follow-up. Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

Cerebrospinal fluid (CSF) cell-free DNA (cfDNA) was found to be a highly effective source for detecting genetic mutations in patients with leptomeningeal metastases (LM) from non-small-cell lung cancer (NSCLC), with 100% detection of driver genes in CSF cfDNA samples.

The study revealed that CSF cfDNA not only captured unique genetic profiles compared to plasma and primary tumor samples but also showed a significantly higher frequency of copy number variations and loss of heterozygosity in key genes like TP53, indicating its potential as a superior liquid biopsy medium for monitoring LM in patients with EGFR mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unique genetic profiles from cerebrospinal fluid cell-free DNA in leptomeningeal metastases of EGFR-mutant non-small-cell lung cancer: a new medium of liquid biopsy. Li, YS., Jiang, BY., Yang, JJ., et al.[2020]

This case study highlights the successful use of next-generation sequencing (NGS) of cerebrospinal fluid (CSF) to identify an uncommon EGFR mutation (G719A) in a 34-year-old male patient with non-small cell lung cancer (NSCLC) and leptomeningeal metastases, which was not detected in peripheral blood.

The patient showed significant clinical improvement and a good response to afatinib therapy over 7 months, demonstrating the efficacy of targeted therapy guided by CSF genetic testing, which proved to be more effective than blood testing in this scenario.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib for Advanced Non-small Cell Lung Cancer in a Case With an Uncommon Epidermal Growth Factor Receptor Mutation (G719A) Identified in the Cerebrospinal Fluid. Ma, C., Huang, C., Tang, D., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7414486/

The relationship between cerebrospinal fluid metastasis and ... Our results revealed that the CSF metastasis of NSCLC patients has a higher frequency of gene mutations and mortality than those without CSF metastasis.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525730424000482

Clinical Lung Cancer The present study investigates the clinical outcomes of patients with NSCLC LMD treated with ETT, ICB, radiotherapy, and/or intrathecal chemotherapy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06816979

Study Details | NCT06816979 | Lumbar Punctures for the ... 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 ...

4. nature.com nature.com/articles/s41698-024-00582-1

Quantification of cerebrospinal fluid tumor DNA in lung ... We profiled 81 CSF, blood, and tissue samples from 24 total patients with advanced lung adenocarcinomas who underwent lumbar puncture (LP) for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3306150/

Multidetector CT-Guided Lumbar Puncture in Patients with ... Multidetector CT-Guided Lumbar Puncture in Patients with Cancer · Results. Successful MDCT guided lumbar puncture was performed in 39 of 41 (95.1%) attempts.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5641214/

Leptomeningeal disease: current diagnostic and therapeutic ... Additional lumbar punctures increase the sensitivity by 2–5% per collection. Each CSF collection should draw 5–10 mL to ensure a sufficient amount for analysis ...

7. moffitt.org moffitt.org/for-healthcare-professionals/clinical-perspectives/clinical-perspectives-story-archive/emerging-therapies-are-showing-promise-for-lmd/

Emerging Therapies are Showing Promise for LMD Cerebrospinal Fluid (CSF) Analysis via Lumbar Puncture: Cytology: Positive in ~50% of cases on the first tap; sensitivity increases with serial ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/334899

CSF Analysis in EGFR Mutant Non-Small Cell Lung ... The aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) ...