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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDigital Photography and Lumbar Puncture

Plus 3 other study approaches.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Mayo Clinic

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: Mayo Clinic
Interventions being studied: Other: Digital Photography; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Device: Medical Device Usage and Evaluation; Procedure: Biospecimen Collection

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Age \>= 18
Prior tissue diagnosis of breast cancer or lung cancer
Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)
Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI
Life expectancy of at least 6 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3
Recovery from any neurotoxic effects of prior therapy
Platelet count greater than 25 x 10\^9/L
Absolute neutrophil count (ANC) greater than 0.5 x 10\^9/L
Patients must have adequate liver function, total bilirubin \< 2.5 mg/dL, unless elevated total bilirubin is due to elevated indirect bilirubin from known Gilbert's disease, aspartate aminotransferase (AST) =\< 3.5 times upper limits of normal; adequate renal function \[calculated estimated glomerular filtration rate (eGFR) \>= 30 mL/min/ body surface area (BSA)\]
Patients or legal medical representative must provide written informed consent
Patients must have suitable body habitus for placement of transducer arrays
Patients must be willing to wear the device for at least 18 hours a day (averaged over monthly)
Patients must be willing to return for the scheduled evaluations and perform the required assessments
Patients are without other disease or situation which would significantly compromise adequate assessment of safety and feasibility of the TTF
Patient willing to start a study treatment with TTF =\< 14 days from registration

Reasons someone may not be able to joinExclusion criteria

Concomitant therapy:
Must not be receiving concurrent high-dose methotrexate (\>= 3 g/m\^2), high dose thiotepa, or high-dose cytarabine (\>= 3 g/m\^2). Any other systemic chemotherapy, targeted treatment, hormonal or immunotherapy directed at the primary systemic malignancy is permitted
Must not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTF
Must be at least 1 week from cessation of any prior intrathecal chemotherapy
Women of childbearing age who are pregnant or lactating. (Male and female patients who are fertile must be willing to use an effective means of birth control to avoid pregnancy)
Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
Patients receiving any other investigational agents and must not have received any other investigational agent within 14 days prior to registration. The 14-day period should be extended if the investigational agent is known to have delayed toxicity
Patients known to be allergic to the hydrophilic gel utilized for transducer attachment
Patients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic in FloridaJacksonville, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 2, 2026. Always confirm current availability with the study team.

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