NCT05746325

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma
• Metastatic Malignant Neoplasm in the Leptomeninges
• Metastatic Lung Carcinoma
• Stage IV Lung Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Digital Photography	Digital photographs taken of array placement
PROCEDURE	Lumbar Puncture	Undergo LP
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DEVICE	Medical Device Usage and Evaluation	Transducer arrays applied and wear NovoTTF-200T
PROCEDURE	Biospecimen Collection	Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously

Timeline

• Start date: 2023-04-07
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2023-02-27
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study