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Medical Device
Electric Field Therapy for Metastatic Breast Cancer
N/A
Recruiting
Led By Kurt A Jaeckle, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)
Prior tissue diagnosis of breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial studies a new treatment for metastatic breast cancer using an electric field device to stop tumor growth. It will help develop better treatments in the future.
Who is the study for?
This trial is for adults with breast cancer that has spread to the spine. Participants must be willing to wear a treatment device for at least 18 hours daily, have good liver and kidney function, an ECOG status of 0-3, and a life expectancy over 6 weeks. They should not be pregnant or breastfeeding, have uncontrolled infections like HIV or hepatitis, allergies to certain gels used in the study, spinal surgical hardware in the treatment area, or recent other treatments.Check my eligibility
What is being tested?
The trial tests a portable device called Novo TTF-200T which emits electric fields aimed at stopping tumor growth in patients with leptomeningeal metastases from breast cancer. It involves wearing the device on the body targeting spinal areas and monitoring its safety and effectiveness through MRI scans and other assessments.See study design
What are the potential side effects?
Potential side effects may include skin irritation where the device attaches, discomfort from wearing it long-term each day, possible headaches or neurological symptoms if affecting brain function due to proximity to spine but specific side effects will be monitored throughout.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to the lining of my brain and spinal cord.
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I have been previously diagnosed with breast cancer through a tissue test.
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I am 18 years old or older.
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I can care for myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of TTFs - estimated the number of patients who are unable to complete at least 30 days of TTF therapy
Incidence of significant toxicity of tumor treating fields (TTFs)
Secondary outcome measures
Preliminary signals of activity (defined as either suspicious or positive cytology).
Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP)
Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP) and adverse events.
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (TTFields, digital photos)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumbar Puncture
2016
Completed Phase 3
~510
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Medical Device Usage and Evaluation
2021
N/A
~150
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,135 Total Patients Enrolled
83 Trials studying Breast Cancer
13,912 Patients Enrolled for Breast Cancer
Kurt A Jaeckle, M.D.Principal InvestigatorMayo Clinic
Kurt A JaecklePrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had brain or spinal cord radiation in the last 2 weeks.I do not have any untreated infections like hepatitis or HIV.My body shape allows for the placement of medical sensor pads.My cancer has spread to the lining of my brain and spinal cord.I have been previously diagnosed with breast cancer through a tissue test.I have recovered from any nerve damage caused by previous treatments.I stopped my spinal chemotherapy at least a week ago.You are allergic to the gel used for the ultrasound machine.My liver and kidney functions are within the required ranges.I am 18 years old or older.Your spinal MRI shows signs of leptomeningeal enhancement in specific areas of your spine.I can care for myself but may not be able to do heavy physical work.I am not pregnant or breastfeeding and willing to use birth control.You are expected to live for at least 6 weeks.Your platelet count and absolute neutrophil count are within certain healthy ranges.I am willing to attend all scheduled appointments and complete necessary tests.I have surgical hardware like rods or screws in my spine.I am not on high-dose methotrexate, thiotepa, or cytarabine.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (TTFields, digital photos)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to participate in this research?
"The clinicaltrials.gov website points to the fact that this research project is not currently recruiting participants, as it was posted on March 10th 2023 and last updated on February 28th of the same year. Nevertheless, there are over 6500 other studies actively enrolling test subjects at this time."
Answered by AI
What is the main purpose behind this clinical research endeavor?
"This long-term trial, which will be monitored for up to three years, aims to estimate the number of patients who may not be able to complete at least 30 days of TTF therapy. As part of this objective and secondary objectives such as preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and MDASI-SP data collection, descriptive analyses will assess time to CSF cytologic response, duration of cytologic response, neurologic progression-free survival timespan between initiation and completion of TTF treatment as well as overall survival rates. Adverse events are also being tracked."
Answered by AI
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