Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Cancer Detection Rate
研究概览
简要总结
The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are:
- Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis?
- Does screening MBI result in more call-backs for biopsy than DBT?
- How well does MBI-guided biopsy conform with pathology reports?
Researchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts.
Participants will
- Receive both screening DBT and screening MBI
- Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images
详细描述
This is a pilot single-group crossover screening clinical trial comparing screening MBI (molecular breast imaging) to screening DBT (3D mammography, digital breast tomosynthesis. Women who have recently completed their annual screening DBT will be assessed for breast density. If they have BI-RADS density C or D (dense breasts), they are eligible for this study. After consent, participants will receive a supplemental screening MBI (crossover from DBT). Both screenings will be read while blinded to knowledge of the other. After independent reporting, a Conciliation Conference will compare the two, and a consensus report will be prepared.
If biopsy is required on the consensus basis of both image sets, then the participant will be randomly assigned to DBT-guided or MBI-guided biopsy. If only one modality has visible lesions that require biopsy, then that modality will be assigned.
The primary outcome measure is Cancer Detection Rate. Secondary outcome measures include Biopsy Callback Rate, Concordance Rate between MBI biopsy sample images and pathology, Time Duration of Biopsy, and Accuracy of Lesion Targeting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
After MBI-guided biopsy samples are placed sequentially in a Petri dish, an MBI image of the samples is taken. This image will be compared to the pathology report for concordance. The Outcomes Assessor will be blinded to patient ID and medical records. Similarly, the pathology report and screening DBT images will be compared.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •dense breasts (BI-RADS C or D) on screening DBT
排除标准
- •pregnancy
研究组 & 干预措施
Breast screening
Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.
干预措施: Molecular Breast Imaging (Device)
Breast screening
Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.
干预措施: MBI-guided biopsy (Device)
结局指标
主要结局
Cancer Detection Rate
时间窗: less than one day
The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality.
次要结局
- Concordance Rate(less than a day)
- Biopsy Call-Back Rate(less than a day)
- Duration of Biopsy(less than a day)