Molecular Breast Imaging (MBI)-Guided Biopsy (MBI-GB-Pilot)

Smart Breast Corp.

Status: Begins enrollment in a year or more

Conditions: Breast Neoplasm; Molecular Imaging; Biopsy; Breast Cancer Detection; Dense Breasts

Treatments: Device: MBI-guided biopsy; Device: Molecular Breast Imaging

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07114679

MBI_Biopsy_Pilot_SBIR

Details and patient eligibility

About

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

Full description

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• dense breasts (BI-RADS C or D) on screening DBT

Exclusion criteria

• pregnancy

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Breast screening

Active Comparator group

Description:

Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.

Treatment:

Device: Molecular Breast Imaging

Device: MBI-guided biopsy