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Procedure

MBI-Guided Biopsy for Breast Cancer

N/A

Recruiting

Led By Katie N. Hunt, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; up to 6 months

Awards & highlights

Study Summary

This trial tests how accurate a new high-res imaging tech (MBI) is in guiding breast biopsy for detecting breast tumors.

Who is the study for?

This trial is for women aged 18 or older who have had a benign breast abnormality detected by MBI in the past 3 years. They must not be pregnant, breastfeeding within the last 2 months, or have had recent breast surgery. Participants need a negative pregnancy test before biopsy if they can become pregnant and must consent to join.Check my eligibility

What is being tested?

The study evaluates high-resolution molecular breast imaging (MBI) as a guide for biopsy in patients with breast abnormalities. It aims to see if MBI is more accurate than ultrasound or mammography when these methods don't show clear images of lesions.See study design

What are the potential side effects?

Potential side effects are related to the Technetium Tc-99m Sestamibi used during scintimammography and may include allergic reactions, radiation exposure risks, and discomfort from the biopsy procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need a biopsy for a breast abnormality found on an imaging test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Accuracy of depth estimation by difference in apparent lesion size

Accuracy of depth estimation by difference in attenuation from opposing views

Accuracy of depth estimation by triangulation

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part II (technetium Tc-99m sestamibi, MBI, biopsy)Experimental Treatment4 Interventions

Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.

Group II: Part I (technetium Tc-99m sestamibi, MBI)Experimental Treatment2 Interventions

Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy of Breast

2012

N/A

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,418 Total Patients Enrolled

83 Trials studying Breast Cancer

13,810 Patients Enrolled for Breast Cancer

Katie N. Hunt, M.D.Principal InvestigatorMayo Clinic in Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being monitored in this trial?

"Affirmative. Evidence found on clinicaltrials.gov implies that this medical study, which was first listed on August 26th 2021, is actively looking for participants. 70 patients are anticipated to be recruited from one location."

Answered by AI

Is enrollment in this research study still open?

"Affirmative. Clinicaltrials.gov affirms that this research project, initially posted on August 26th 2021, is currently recruiting participants. There are 70 vacancies at a single medical centre for prospective patients to consider joining the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06058650.