RecruitingNot ApplicableNCT05746325

Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine


Sponsor

Mayo Clinic

Enrollment

5 participants

Start Date

Apr 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable device that delivers low-level electrical fields (called Tumor Treating Fields) to the spine in patients with breast or lung cancer that has spread to the lining of the spinal cord (called leptomeningeal metastases), a very serious and difficult-to-treat complication. **You may be eligible if...** - You are 18 or older - You have a prior diagnosis of breast cancer or lung cancer - Your cancer has spread to the lining of the spinal cord, confirmed by spinal MRI and spinal fluid testing - You are willing to wear the device for at least 18 hours per day - Your general health level meets the study criteria (ECOG 0–3) - You have adequate blood counts and organ function **You may NOT be eligible if...** - Your cancer spread to the spinal lining has not been confirmed with both imaging and fluid testing - Your body shape does not allow the device to be properly fitted - You are unable to attend scheduled follow-up visits - You have another serious condition that would interfere with safety assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDigital Photography

Digital photographs taken of array placement

PROCEDURELumbar Puncture

Undergo LP

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DEVICEMedical Device Usage and Evaluation

Transducer arrays applied and wear NovoTTF-200T

PROCEDUREBiospecimen Collection

Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT05746325


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