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

NCT05746325 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-04-02

No results posted yet for this 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.

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

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

Sponsors & Collaborators

Principal Investigators

  • Wendy J. Sherman, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-07
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05746325 on ClinicalTrials.gov