Molecular Breast Imaging (MBI)-Guided Biopsy for Dense Breasts

This study is looking at a new way to find breast cancer called Molecular Breast Imaging (MBI) in women with dense breasts. MBI uses a special injection and cameras to highlight cancer cells. Researchers want to see if MBI finds more cancers than standard 3D mammograms (DBT) and if it leads to more biopsies. They also want to check how well MBI-guided biopsies match pathology results. You could join if you are a woman aged 21 or older with dense breasts (BI-RADS C or D). The study aims to enroll 250 participants. The current status of the study is unclear.

Study design
This is a pilot single-group crossover study comparing MBI to DBT. It plans to enroll 250 women.
What's involved
You will receive both a screening DBT and a supplemental screening MBI. If a biopsy is needed, you will be randomly assigned to either a DBT-guided or MBI-guided biopsy.
Compensation
Not stated in the trial record.
Follow-up
Cancer detection rate is measured at less than one day after screening.

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NCT07114679

Molecular Breast Imaging (MBI)-Guided Biopsy

Not Yet Recruiting
NAAges 21+InterventionalScreening
Smart Breast Corp.
~250 participants
Updated 2025-08-11 on ClinicalTrials.gov
What's tested:Molecular Breast ImagingMBI-guided biopsy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cancer Detection Rate
Measured over less than one day
Breast Cancer Detection
Breast Neoplasm
Molecular Imaging
Biopsy
Dense Breasts
1 sites across 1 states
Texas1
  • James W Hugg, PhD · PRINCIPAL_INVESTIGATOR · Smart Breast Corp.

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

pregnancy
  • Cancer Detection Rateless 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.