Electric field device tested for spine cancer spread
NCT ID NCT05746325
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests if a portable device that creates electric fields is safe and practical for people with breast or lung cancer that has spread to the lining of the spine. Only 5 participants will wear the device for at least 28 days. The goal is to see if the treatment is tolerable and to gather information for future research.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224-9980, United States
Contact Email: •••••@•••••
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