OctavaPink® For Dense Breast After Negative Mammography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,750
- 试验地点
- 7
- 主要终点
- Positive MRI as an approval for a positive OctavaPink test
研究概览
简要总结
The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3 or 4). The device is intended to increase breast cancer detection in the described patient population. Based upon the result of OctavaPink, the patient will be further evaluated by their physician.
详细描述
This is a multicenter, prospective study containing 3 parts:
Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as follows:
Part 1A will optimize the OctavaPink test for women with dense breast tissue, and will not affect the treatment of the participants. Part 1A is an internal part done by EventusDx and no statistical evaluation is needed.
Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70% sensitivity.
Part 1B will assess the properties of the OctavaPink test using cases and controls obtained via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control status before using the test to affect clinical management of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects with dense breast tissue according to ACR criteria, (BIRADS composition/density 3 or 4), or with specific area of high density behind the nipple.
- •Subject with current mammography BIRADS assessment category other than
- •Signed inform consent form.
- •Additional inclusion criteria for Part 1A and Part 1B cases and Part 3 cases
- •Subjects with current biopsy/surgery proven breast cancer.
- •Additional inclusion criteria for Part 1A controls, Part 1B controls • Subjects with current negative mammography (BIRADS assessment category 1 or 2).
- •Additional inclusion criteria for Part 2
- •Subjects with current negative mammography (BIRADS assessment category 1 or 2). All will perform an additional 1 year (12-18 months) up mammography to verify negative results.
- •Additional inclusion criteria for Part 3 • Enriched patient population - Subjects with current/recent (less than 12 months) negative mammography (BIRADS assessment category 1 or 2). Mammography evaluation can be performed after recruiting.
排除标准
- •Previous or concurrent malignancies of any type except for basal cell carcinoma of the skin, squamous-cell carcinoma of the skin or cervical carcinoma in situ.
- •Previous or current ADH, ALH, LCIS.
- •Autoimmune disorders diagnosed subjects.
- •Hematological malignancies.
- •Subjects under active chemotherapy treatment or chemotherapy in the past 6 months.
- •Steroid treatment in the past 3 months.
- •Subject undergoing immunosuppressive treatments.
- •Subject with current mammography BIRADS assessment category of
- •Pregnancy at time of recruitment.
- •Doctor medical judgment that prohibits participation in the study.
- •Participating in a parallel clinical study that involves drug treatment, or may influence the course of this clinical trial.
- •Additional exclusion criteria for Part 3
- •Subjects with current mammography BIRADS assessment other than 1 or 2.
结局指标
主要结局
Positive MRI as an approval for a positive OctavaPink test
时间窗: Approximately two month following a positive Octava test
次要结局
未报告次要终点