NCT00020852已完成1 期
Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions.
PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions.
详细描述
OBJECTIVES:
- Determine the feasibility of temperature-monitored, ultrasound-guided cryosurgery in women with highly suspicious breast lesions.
- Determine the safety of this procedure in these patients.
OUTLINE: This is a multicenter study.
Patients undergo cryoablation of up to two breast lesions. Within 3-21 days, patients undergo lumpectomy or mastectomy.
Patients are followed at 1, 4, 8, and 12 weeks after lumpectomy or mastectomy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Highly suspicious breast lesion on prior mammogram and/or ultrasound with confirmation of malignancy on ultrasound-guided core biopsy
- •Tumor no greater than 2.0 cm in diameter
- •Eligible for lumpectomy or mastectomy
- •No superficial breast lesions
- •No prior open surgical biopsy
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No other illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •No other surgery that would preclude study participation
- •No other medical treatment that would preclude study participation
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Cryosurgery in Treating Patients With Liver Cancer or Liver MetastasesMetastatic CancerLiver CancerNCT00002655University of Colorado, Denver
已完成
1 期
Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung MetastasisMetastatic CancerLung CancerNCT00890617Barbara Ann Karmanos Cancer Institute9
终止
1 期
Cryosurgery in Treating Patients With Soft Tissue SarcomaSarcomaNCT00002863University of Southern California19
已完成
不适用
Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By SurgeryMetastatic CancerLung CancerNCT00303901Barbara Ann Karmanos Cancer Institute40
已完成
2 期
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung CancerKidney CancerMetastatic CancerUnspecified Adult Solid Tumor, Protocol SpecificLung CancerNCT00514215Barbara Ann Karmanos Cancer Institute8