Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Measure protocol accuracy
研究概览
简要总结
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.
详细描述
FirstSense Medical, LLC is a medical device company which has developed a breast cancer screening device, the Sentinel BreastScan II [SBS II]. This radiation free device is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr. Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. The SBS II examination will take approximately 7 minutes.
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging. Currently, mammography is one of the standards of care in screening for visible signs of breast cancer. Breast thermology is the analysis of the heat signature data from an examined breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to participate. All scientific data revealed in this protocol will be used for the specific objectives of the study. The SBS II is a non-significant risk device. There is no contact with the subject during the entire procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female, over the age of 18 years of age.
- •Asymptomatic women or women who are being screened for breast abnormality.
- •Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
- •Not pregnant or breast feeding.
- •Signed Informed consent.
排除标准
- •Subject does not meet inclusion criteria, noted above.
- •Use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours.
- •Use of nitroglycerin within the last 24 hours.
- •Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
- •Subject must not have had a mammogram, breast ultrasound, or breast exam within the last 72 hours prior to the SBS II.
结局指标
主要结局
Measure protocol accuracy
时间窗: Through study completion, an average of 4 years.
To measure the sensitivity and specificity of thermographic analysis based on the Marseilles analytic protocol \[ Th 1 thru 5 \] to biopsy results predicated on standard breast imaging criteria \[ BIRADS analytical protocol, B1 thru B5 \]. The resultant BIRADS score and biopsy pathological results will be compared to thermographic analysis \[ Th1 thru 5 \] for each subject. 50 subjects undergoing both thermography and standard breast imaging leading to biopsy \[ BIRADS 3 thru 5 \] will then be compared by measuring the results of each, BIRADS for standard breast imaging v the Marseilles Th system used in thermographic analysis, for concordance or discordance of findings as measured on final pathological analysis. This analysis will be performed for each subsequent 50 patient cohort undergoing standard mammographic/ultrasound breast imaging analysis.
次要结局
未报告次要终点