Recruiting

Tumor Treating Fields

Sponsor:

Mayo Clinic

Code:

NCT05746325

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Photography

Lumbar Puncture

Magnetic Resonance Imaging

Medical Device Usage and Evaluation

Biospecimen Collection

Study Details

Brief 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

Study ID

NCT05746325

Start date

Apr 7, 2023

Status verified date

Mar, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion 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)

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (TTFields, digital photos)

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 and may undergo LP during screening and on study.

Interventions

Digital Photography

Digital photographs taken of array placement

Lumbar Puncture

Undergo LP

Magnetic Resonance Imaging

Undergo MRI

Medical Device Usage and Evaluation

Transducer arrays applied and wear NovoTTF-200T

Biospecimen Collection

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

Primary outcome measure

  • Incidence of significant toxicity of tumor treating fields (TTFs) [ Time Frame: Up to 3 years ]
  • Feasibility of TTFs - completion of at least 28 days of TTF therapy [ Time Frame: Up to 28 days ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Wendy J. Sherman, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-02.