Image-Guided Pulsed Electric Field (PEF) Ablation of Soft Tissue Lesions in Metastatic Breast Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of participants with treatment-emergent adverse events
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. To assess the safety of PEF for locoregional treatment of soft tissue metastatic breast cancer lesions.
SECONDARY OBJECTIVE:
I. To assess the effect of PEF on patient-reported symptoms and quality of life.
II. To assess the feasibility of performing PEF for superficial soft tissue metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically or cytologically confirmed metastatic breast cancer.
- •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.
- •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.
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Adequate Bone Marrow Function:
- •Absolute neutrophil count ≥1,500/microliter (mcL).
- •Platelets ≥100,000/mcL.
- •Not on or able to withhold anticoagulation or antiplatelet therapy per Society of Interventional Radiology periprocedural guideline.
- •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.
- •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.
- •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).
- •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.
- •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.
排除标准
- •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).
- •Individuals with pacemakers or other electronic implant devices.
- •Individuals who are unable or unwilling, or with medical contraindication, to undergo moderate sedation and local anesthesia.
- •Pregnant individuals are excluded from this study because there is unknown risk of PEF on fetus.
- •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.
- •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.
研究组 & 干预措施
Image-Guided Pulsed Electric Field (PEF) Ablation
Participants undergo a single treatment of PEF ablation delivered to up to 3 soft tissue metastatic breast cancer lesion(s). Ablation parameters, immediate adverse events, and post-ablation imaging will be collected during the ablation treatment.
干预措施: Pulsed Electric Field (PEF) System (Device)
Image-Guided Pulsed Electric Field (PEF) Ablation
Participants undergo a single treatment of PEF ablation delivered to up to 3 soft tissue metastatic breast cancer lesion(s). Ablation parameters, immediate adverse events, and post-ablation imaging will be collected during the ablation treatment.
干预措施: Questionnaires (Behavioral)
Image-Guided Pulsed Electric Field (PEF) Ablation
Participants undergo a single treatment of PEF ablation delivered to up to 3 soft tissue metastatic breast cancer lesion(s). Ablation parameters, immediate adverse events, and post-ablation imaging will be collected during the ablation treatment.
干预措施: Tumor Ablation (Procedure)
结局指标
主要结局
Proportion of participants with treatment-emergent adverse events
时间窗: Up to 4 weeks
Proportion of participants who experience adverse event from the Pulsed Electric Field (PEF) ablation treatment. Standard deviation and 95% confidence intervals will be reported.
次要结局
- Mean change of score on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ BR-23)(Up to 4 weeks)
- Mean change of score on EuroQol five-dimensional Questionnaire (EQ-5D)(Up to 4 weeks)
- Mean technical success rate of Pulsed Electric Field (PEF) ablation(Up to 1 day)