Molecular Breast Imaging (MBI)-Guided Biopsy

Condition(s) studied

Investigational drug(s) / intervention(s)

Molecular Breast Imaging: MBI is a molecular imaging (nuclear medicine) technique using a low dose i.v. radiopharmaceutical injection and solid-state gamma cameras to image the breast, where cancer mitochondria avidly take up the radiopharmaceutical.

MBI-guided biopsy: Two stereotactic MBI views of the breast produce a precise 3D location for each lesion targeted for biopsy. A vacuum-assisted core biopsy needle is guided to the lesion position.

Study summary

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

Eligibility

Primary outcome measure(s)

• Cancer Detection Rate — 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.

Trial sites (1)

Other trials for the same condition