About this trial
This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken. Sometimes a lesion or part of the lesion cannot be seen on ultrasound or mammography, and, therefore, a biopsy guided with ultrasound or mammography may not be always be accurate. Studies have shown that high resolution MBI may have potential to improve the detection of some breast tumors. This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI.
Eligibility criteria
Qualifiers
PART I: Women aged 18 years or older
PART I: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure
PART I: Individuals who have previously (within the last 3 years) undergo an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or follow-up) to be benign in nature
PART I: Individuals who have agreed to participate in the study and who have signed the study-specific informed consent
Disqualifiers
PART I: Women who are pregnant
PART I: Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study
PART I: Age less than 18 years
PART I: Women with breast implant(s) in the breast containing the lesion of interest
Trial design
Treatments tested in this trial
- Biopsy of Breast
- Medical Device Usage and Evaluation
- Scintimammography
- Technetium Tc-99m Sestamibi