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Recruiting NCT06058650

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

Trial Parameters

Condition Breast Neoplasm
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2021-08-26
Completion 2026-08-26
Interventions
Biopsy of BreastMedical Device Usage and EvaluationScintimammography

Brief Summary

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

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 h

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