RecruitingNot applicable

Pulsed Electric Field Ablation for Metastatic Breast Cancer

Image-Guided Pulsed Electric Field (PEF) Ablation of Soft Tissue Lesions in Metastatic Breast Cancer: A Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After the treatment, participants are followed at Day 0, week 2, week 4, and up to 1 year post ablation."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the safety of using short pulses of electricity to destroy tumors with the Aliya Pulsed Electric Field System. It is for adults with breast cancer that has spread and has tumors in or just under the skin. Doctors use medical images to guide treatment of up to 3 tumors.

This is a phase I trial of the safety of image-guided pulsed electric field (PEF) ablation for the locoregional treatment of superficial soft tissue lesions in adults with metastatic breast cancer using the AliyaTM Pulsed Electric Field System.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18 or older and have breast cancer that has spread, confirmed by a tissue or cell test.
  • Scans or a biopsy must show cancer in soft tissue. At least one tumor must be in or just under the skin, measure 1–5 cm, and be safe to reach using image guidance.
  • You may have had any number of cancer treatments. Your doctors must agree that you can pause whole-body breast cancer treatment for 1 week before and 2 weeks after the procedure.
  • You must be able to care for yourself and be out of bed or a chair for more than half of your waking hours. Blood tests must show enough infection-fighting cells and platelets, which help blood clot.
  • You must not take blood-thinning medicines, or you must be able to safely pause them under procedure guidelines.
  • If you have HIV, treatment must be working, with no virus detected within 6 months. Chronic hepatitis B must be undetectable with treatment if needed. Hepatitis C must be cured or undetectable during treatment.
  • A past or current second cancer is allowed if it will not affect how doctors judge this treatment’s safety or results.
  • If you can become pregnant, you must use birth control or avoid sex during the study and for 4 weeks after the last treatment. Tell your doctor right away if you become pregnant or think you may be pregnant.

Who can't join

  • Side effects from past or current whole-body cancer treatment have not returned to your usual level or improved to moderate or milder. Hair loss does not count.
  • You have a pacemaker or another electronic device implanted in your body.
  • You cannot or do not want to receive medicine to relax you and numb the treatment area.
  • You are pregnant, because the risks to an unborn baby are unknown.
  • You are breastfeeding or chestfeeding. You must stop before study treatment because the risks to a nursing baby are unknown.
  • The study doctor believes a health condition or life situation would keep you from following study procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed metastatic breast cancer. 2. Confirmed documented soft tissue involvement via imaging or biopsy, with at least one measurable lesion with a cutaneous and/or subcutaneous component that is at least 1 cm in size but no greater than 5 cm in size and that can be safely accessed under image guidance. Up to 3 lesions that meet these criteria may be treated with PEF ablation therapy. 3. There are no limits on the amount of prior or concurrent anti-cancer therapies, but patients must be medically able (in the opinion of referring provider and treating investigator) to withhold their systemic therapy for breast cancer one week before the PEF ablation and for 2 weeks after the procedure. 4. Age ≥18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 6. Adequate Bone Marrow Function: 1. Absolute neutrophil count ≥1,500/microliter (mcL). 2. Platelets ≥100,000/mcL. 7. Not on or able to withhold anticoagulation or antiplatelet therapy per Society of Interventional Radiology periprocedural guideline. 8. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months (as documented in the medical record) are eligible for this trial. 9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy (as documented in the medical record), if indicated. 10. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load (as documented in the medical record). 11. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 12. The effects of pulsed electric field on the developing human fetus are unknown. For this reason individuals of reproductive potential must agree to use adequate contraception: (e.g., hormonal or barrier method of birth control; abstinence, etc.) for the duration of study participation and for 4 weeks after last administration of study treatment. Should a study participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately. Exclusion Criteria: 1. Has not recovered from adverse events due to prior/concurrent systemic anti-cancer therapy to ≤ Grade 2 (CTCAE v5.0) or baseline (other than alopecia). 2. Individuals with pacemakers or other electronic implant devices. 3. Individuals who are unable or unwilling, or with medical contraindication, to undergo moderate sedation and local anesthesia. 4. Pregnant individuals are excluded from this study because there is unknown risk of PEF on fetus. 5. Breastfeeding/chestfeeding individuals are excluded from this study because there is unknown risk on nursing infants; breastfeeding/chestfeeding should be discontinued prior to initiating study treatment. 6. Individuals with any condition or social circumstance that, in the opinion of the treating investigator, would impair the participant's ability to comply with study procedures.

Study sites (1)

CA