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

Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI."
  • "To evaluate a methodology for MBI-guided biopsy of suspicious breast lesions."
  • "Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new molecular breast imaging (MBI) system to guide a breast biopsy, which takes a small tissue sample for testing. It is for women age 18 or older with breast findings seen on imaging.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both parts: Women age 18 or older.
  • Both parts: If you can become pregnant, you must have a negative pregnancy test within 48 hours before the MBI biopsy.
  • Both parts: You must agree to join and sign the study consent form.
  • Part I: An MBI scan within the past 3 years showed a breast finding that later tests or follow-up showed was not cancer.
  • Part II: An MBI scan within the past 3 years showed a breast finding that later tests or follow-up showed was not cancer or probably not cancer.
  • Part II: Recent breast imaging must show a finding needing or recommended for biopsy. The criteria also list findings rated BI-RADS 3 or higher that need follow-up imaging or a biopsy.

Who can't join

  • Both parts: You are under age 18, are pregnant, or cannot give informed consent.
  • Both parts: You are breastfeeding or stopped breastfeeding less than 2 months before the study.
  • Both parts: You have an implant in the breast with the finding being studied.
  • Part II: You had a biopsy of the breast finding within the past 3 months.
  • Part II: You are scheduled for a sentinel node test, which checks lymph nodes, using radioactive Tc-99m within 24 hours of the MBI-guided biopsy.
  • Part II: A health problem, such as a blood-clotting disorder or infection, makes a tissue-sampling biopsy or another procedure unsafe.
  • Part II: You are unwilling to stop taking blood-thinning medicine before the procedure.
  • Part II: You had surgery on the breast being studied within the past 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * PART II: Women aged 18 years or older * PART II: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure * PART II: Individuals who have previously (within the last 3 years) undergone 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 or probably benign in nature * PART II: Individuals who had recent conventional imaging work-up including either x-ray mammography, ultrasound, MBI, or MRI of the breast and are found to have at least one breast imaging finding for which biopsy is required or recommended, specifically: * Individuals who have a breast abnormality(ies) on imaging with mammography, ultrasound, MBI, or MRI (as per American College of Radiology \[ACR\] Breast Imaging Reporting and Data System \[BIRADS\] 3, or higher) and requiring imaging follow-up or biopsy confirmation * PART II: Individuals who have agreed to participate in the study and who have signed study-specific informed consent Exclusion Criteria: * 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 * PART I: Inability to provide informed consent * PART II: Women who are pregnant * PART II: Women who are currently lactating or discontinued breastfeeding \< 2 months prior to the study * PART II: Age less than 18 years * PART II: Women with breast implant(s) in the breast containing the lesion of interest * PART II: Women who have recently (within the last 3 months) undergone biopsy of the breast finding * PART II: Women who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of MBI-guided biopsy * PART II: Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure * PART II: Inability to provide informed consent * PART II: Women who have had surgery on the study breast(s) within the past 12 months

Study sites (1)

MN