New breast imaging could make biopsies more accurate
NCT ID NCT06058650
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether molecular breast imaging (MBI) can guide biopsies for breast abnormalities that are hard to see on ultrasound or mammography. About 70 women with a prior MBI finding that turned out to be benign will undergo a new MBI-guided biopsy procedure. The goal is to see if MBI can accurately target the lesion and improve biopsy success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Technetium Tc-99m Sestamibi
- What this could lead to
- If successful, this could make breast biopsies more accurate for lesions that are hard to see on standard imaging, potentially reducing missed cancers.
- What could go wrong
- This is a small pilot study (70 people) focused on workflow and accuracy, not on patient outcomes. The technique may not prove better than current methods or may be too slow for routine use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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