NCT05032079撤回不适用
Pilot Study for the Cryoablation of Ductal Carcinoma In Situ: Subzero and Scorpion Trial
Larkin Community Hospital2 个研究点 分布在 1 个国家开始时间: 2020年11月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- complete tumor ablation
研究概览
简要总结
This is a prospective single-institution pilot study examining the feasibility of performing ultrasound-guided cryoablation to completely ablate breast ductal carcinoma in situ (DCIS). The study is designed such that patients meeting selection criteria will undergo cryoablation followed by surgical resection. The pathology of the surgical specimen will be used to determine the rate of complete tumor ablation. Standard adjuvant therapies otherwise remained unchanged.
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 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-registration core biopsy:
- •Unifocal primary ductal carcinoma in situ (DCIS) or atypical ductal hyperplasia (ADH) bordering on DCIS or DCIS with microinvasion diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer are NOT eligible. Patients with contralateral disease will remain eligible.
- •Tumor size < 1.5 cm in greatest diameter. Specifically, the tumor must measure < 1.5 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 required pre-treatment scans (mammogram, ultrasound and MRI) will be used to determine eligibility.
- •An ultrasound visible target for cryoablation:
- •Ultrasound-visible mass or nonmass finding corresponding to the tumor or An ultrasound-visible biopsy marker placed within 1cm of the biopsied tumor.
- •No prior or planned neoadjuvant chemotherapy for breast cancer.
- •Adequate breast size for safe cryoablation. This will be determined by the interventional radiologist using a combination of clinical exam and imaging. Site of target for cryoablation must be greater than 1 cm from the nipple and greater than 1cm from the closest skin surface.
排除标准
- •Multifocal of multicentric carcinoma.
- •Pre-registration core biopsy with diagnosis of frank invasive carcinoma (not microinvasion) or lobular carcinoma.
- •Prior or planned neoadjuvant chemotherapy for breast cancer.
- •Retroglandular breast implants. (Please note that patients with retropectoral implants are allowed to enroll if they meet all other inclusion criteria.)
研究组 & 干预措施
Treatment Arm
Experimental
干预措施: cryoablation (Procedure)
结局指标
主要结局
complete tumor ablation
时间窗: 2 years
rate of complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of excised tissue
次要结局
未报告次要终点
研究者
研究点 (2)
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