A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
研究概览
简要总结
This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the procedural success rate of using the Visualase magnetic resonance (MR)-guided laser system to target, access, thermally monitor, and focally ablate MR-visible breast cancer lesions.
- To obtain preliminary data on ablative success using pathologic assessment for specimen excised subsequent to the ablation.
OUTLINE:
Patients undergo MR-thermal image guided laser interstitial thermal therapy (LITT) over 1 hour.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal state
- •Histological diagnosis of breast invasive ductal carcinoma with receptor profiles obtained
- •MRI visible breast lesion
- •Unifocal cancer, less than 1.5 cm in maximum diameter (clinical stage T1), with no evidence of extensive in situ cancer surrounding the main tumor; the eligibility will be determined by the MR imaging appearance of the tumor; if the tumor (proven invasive ductal carcinoma) is a unifocal mass without additional enhancement, it will be judged eligible; however, if the tumor is associated with additional enhancement and/or a satellite focus, it will not judged ineligible, as these are signs of additional in situ or invasive cancer
- •Clinical stage N0 (no metastatic axillary lymph node on physical examination or imaging work-up)
- •Ability to give informed consent
排除标准
- •Previous surgery or radiation for the ipsilateral breast cancer
- •Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
- •Tumor located less than 1 cm from the skin or the pectoralis muscle
结局指标
主要结局
Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
时间窗: Up to 7 days
Frequency of not completing the procedure due to patient's discomfort
时间窗: Up to 7 days
Observed thermal damage on skin
时间窗: Up to 7 days
Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes.
次要结局
- Amount of tumor necrosis(Up to 7 days)
- Amount of viable tumor(Up to 7 days)