Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Incidence of treatment-emergent adverse events [safety]
研究概览
简要总结
This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.
Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy;
- •Tumor visible by ultrasound at time of treatment;
- •Unifocal primary disease;
- •Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound);
- •Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex;
- •Planned lumpectomy
排除标准
- •Pregnant patients
- •Multifocal or metastatic disease
- •Planned neoadjuvant chemotherapy or radiation
- •Extensive ductal carcinoma in situ (DCIS; >25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging
- •Known allergy to both lidocaine and benzocaine
研究组 & 干预措施
Cryoablation
Participants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery).
干预措施: Cryoablation (Procedure)
Control
Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care).
结局指标
主要结局
Incidence of treatment-emergent adverse events [safety]
时间窗: 1 day after cryoablation
Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes
Immune response
时间窗: One week after lumpectomy
Immunohistochemical analysis of biomarkers in blood and resected tissue
Cosmetic outcome
时间窗: Change from one month to one year after lumpectomy
Change in appearance based on distortion and volume loss of the breast
Tumor margin status [effectiveness]
时间窗: 7-10 days after lumpectomy
Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required
次要结局
未报告次要终点