NCT01780532撤回不适用
Pilot Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The lesion visibility on PAI, described using a five-level scale: 1. Not visible 2. Barely visible 3. Fair (or moderately visible) 4. Visible 5. Clearly visible.
研究概览
简要总结
After locating the suspicious lesion/mass with standard of care mammography and/or ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located. After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram and ultrasound only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have a breast lesion/mass found at physical examination, mammography or ultrasound (US), that has not been surgically resected
- •Patients may have any of the following characteristics:
- •Taking hormones (e.g., contraceptives, hormone replacement therapy, post-cancer Tamoxifen)
- •Breast implants
- •Previous breast biopsy
- •Previous breast surgery
- •Previous breast cancer
- •High risk of breast cancer (e.g., breast cancer susceptibility gene (BRCA) mutations, other gynecologic cancer)
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have had primary surgical excision of the suspicious finding
- •Pregnant or lactating women
研究组 & 干预措施
Photo Acoustic Imaging
Experimental
An exploratory, single armed, pilot study designed to evaluate the feasibility of Photo Acoustic Imaging (PAI) in a clinical setting.
干预措施: Photoacoustic Imaging (PAI) (Procedure)
结局指标
主要结局
The lesion visibility on PAI, described using a five-level scale: 1. Not visible 2. Barely visible 3. Fair (or moderately visible) 4. Visible 5. Clearly visible.
时间窗: 6 months
次要结局
- Measures of hypoxia in the lesion(6 months)
研究者
Sanjiv Sam Gambhir
Chair, Dept. of Radiology
Stanford University
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