RECRUITING

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

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Conditions

Breast Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-26
Study Completion:2026-08-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06058650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PART I: Women aged 18 years or older
  2. * PART I: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure
  3. * 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
  4. * PART I: Individuals who have agreed to participate in the study and who have signed the study-specific informed consent
  5. * PART II: Women aged 18 years or older
  6. * PART II: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure
  7. * 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
  8. * 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:
  9. * 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
  10. * PART II: Individuals who have agreed to participate in the study and who have signed study-specific informed consent
  1. * PART I: Women who are pregnant
  2. * PART I: Women who are currently lactating or discontinued breastfeeding \< 2 months prior to the study
  3. * PART I: Age less than 18 years
  4. * PART I: Women with breast implant(s) in the breast containing the lesion of interest
  5. * PART I: Inability to provide informed consent
  6. * PART II: Women who are pregnant
  7. * PART II: Women who are currently lactating or discontinued breastfeeding \< 2 months prior to the study
  8. * PART II: Age less than 18 years
  9. * PART II: Women with breast implant(s) in the breast containing the lesion of interest
  10. * PART II: Women who have recently (within the last 3 months) undergone biopsy of the breast finding
  11. * PART II: Women who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of MBI-guided biopsy
  12. * 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
  13. * PART II: Inability to provide informed consent
  14. * PART II: Women who have had surgery on the study breast(s) within the past 12 months

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Katie N. Hunt, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Katie N. Hunt, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-26
Study Completion Date2026-08-26

Study Record Updates

Study Start Date2021-08-26
Study Completion Date2026-08-26

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Neoplasm