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Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine
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.
PRIMARY OBJECTIVE: I. To determine whether the TTF device can be successfully placed in the three protocol-specified treatment field arrays (cervical, thoracic, and lumbar) and worn by the study patients for a meaningful period of time in the treatment of leptomeningeal metastases within the spine. SECONDARY OBJECTIVE: I. To document any preliminary signals of activity, as measured by radiographic and clinical response, or durable stability of objective neurologic examination, utilizing Leptomeningeal Assessment in Neuro-Oncology (LANO) criteria, magnetic resonance imaging (MRI) imaging, cerebrospinal fluid (CSF) cytologic examination, and patient-reported symptom assessment (M. D. Anderson Symptom Inventory \[MDASI\]-spine module). OUTLINE: Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI during screening and on study and may undergo lumbar puncture (LP) and collection of cerebrospinal fluid (CSF) samples during screening if no CSF testing for malignancy has been done previously. After completion of study intervention, patients are followed up every 3 months or every 6 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Florida
Jacksonville, Florida, United States
Start Date
April 7, 2023
Primary Completion Date
March 1, 2027
Completion Date
March 1, 2027
Last Updated
October 27, 2025
5
ESTIMATED participants
Digital Photography
OTHER
Lumbar Puncture
PROCEDURE
Magnetic Resonance Imaging
PROCEDURE
Medical Device Usage and Evaluation
DEVICE
Biospecimen Collection
PROCEDURE
Lead Sponsor
Mayo Clinic
NCT04550494
NCT04704661
Data Source & Attribution
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