Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

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

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators