A Pilot Study to Determine the Efficacy of Cryoablation for the Treatment of Invasive Breast Carcinoma Following Neoadjuvant Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of Complete Tumor Ablation
研究概览
简要总结
Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue.
The goal of this clinical research study is to learn about the level of effectiveness of using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of this procedure will also be studied.
详细描述
Study Procedure:
To perform cryoablation in this study, the doctor will insert the cryoprobe like a needle until the tip rests in about the middle of the cancerous area. In this study, an ultrasound imaging device will also be used to allow the doctor to see where to insert the cryoprobe.
If you are found to be eligible and agree to take part in this study, you will have an ultrasound-guided biopsy to confirm your diagnosis. To perform an ultrasound-guided biopsy, a tissue sample will be withdrawn from your breast using a needle and a syringe. A very small amount of tissue will be taken. The needle is guided while being viewed by the doctor on an ultrasound.
Cryoablation:
Before you have the cryoablation procedure, blood (about 1 teaspoon) will be drawn for routine tests. Within 30 days after you join this study, the cryoablation procedure will be performed. The affected area will first be numbed with anesthetic. Your study doctor will insert the cryoprobe needle and use an ultrasound device to help guide the cryoprobe until it reaches the cancerous area.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or ductal carcinoma in situ (DCIS) with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible.
- •Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required.
- •Residual tumor size </= 2.0 cm in greatest diameter. Specifically, the tumor must measure </= 2.0 cm in the axis parallel to the treatment probe and </= 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility.
- •Tumor enhancement on pre-registration MRI.
- •Tumor with <25% intraductal components in the aggregate.
- •Adequate breast size for safe cryoablation. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation.
- •Patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. Patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible.
排除标准
- •History of open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure.
- •Pregnant and/or lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential.
- •Patient has contra-indication to an MRI examination, such as clips/prostheses/implants that are not MRI compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m^2
- •Patients less than 18 years of age will not be included in this study.
研究组 & 干预措施
Cryoablation
Cryoablation therapy followed by re-imaging then complete surgical resection.
干预措施: Visica 2™ Treatment System (Device)
Cryoablation
Cryoablation therapy followed by re-imaging then complete surgical resection.
干预措施: Cryoablation (Procedure)
Cryoablation
Cryoablation therapy followed by re-imaging then complete surgical resection.
干预措施: Surgical Resection (Procedure)
结局指标
主要结局
Rate of Complete Tumor Ablation
时间窗: From cryoablation through 30 days from surgery
The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.
次要结局
未报告次要终点