Breast NeoplasmNCT06058650
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
A study testing Biopsy of Breast, Medical Device Usage and Evaluation and Scintimammography in people with Breast Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Biopsy of Breast, Medical Device Usage and Evaluation and Scintimammography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2021to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Katie N. Hunt, M.D.
About this study
Official title: Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate a methodology for MBI-guided biopsy of suspicious breast lesions.
OUTLINE: Patients are assigned to 1 of 2 study parts.
PART I: Patients receive technetium Tc-99m sestamibi intravenously (IV) and undergo MBI on study.
PART II: 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.
After completion of study intervention, patients may be asked to follow up at 3-6 months.
- Conditions
- Breast Neoplasm
- Being tested
- Biopsy of Breast, Medical Device Usage and Evaluation, Scintimammography, Technetium Tc-99m Sestamibi
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of BreastProcedure or surgery
Also called Breast Biopsy
Undergo biopsy of breast
Medical Device Usage and EvaluationOther
Utilization of the Stereo Navigator accessory
ScintimammographyRadiation
Also called Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma Test
Undergo MBI
Technetium Tc-99m SestamibiOther
Also called Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Part I (technetium Tc-99m sestamibi, MBI) | Experimental | Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study. Receives: Radiation: Scintimammography; Other: Technetium Tc-99m Sestamibi |
| Part II (technetium Tc-99m sestamibi, MBI, biopsy) | Experimental | 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. Receives: Procedure: Biopsy of Breast; Other: Medical Device Usage and Evaluation; Radiation: Scintimammography; Other: Technetium Tc-99m Sestamibi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of timeframe
Time from injection of the technetium Tc-99m sestamibi to identification of the appropriate needle guide hole will be reviewed to determine if and where any improvements in workflow can be made to reduce the overall procedure time for patients.
Measured: Baseline
Change in image of lesion
The coordinates of the lesion of interest on the high resolution MBI image will be recorded. The guidance procedure will be considered successful if 1) the pre and post images of the lesion demonstrated one of the following: decreased in size, central or eccentric defect where sampled, or decrease in intensity, or 2) pathology results demonstrate malignancy or a specific benign concordant result.
Measured: Baseline; Up to 6 months
Accuracy of depth estimation by difference in attenuation from opposing views
For each patient in whom pathology confirms successful sampling of the lesion seen on high-resolution molecular breast imaging (MBI), the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.
Measured: Baseline; Up to 6 months
Accuracy of depth estimation by difference in apparent lesion size
For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.
Measured: Baseline; Up to 6 months
Accuracy of depth estimation by triangulation
For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.
Measured: Baseline; Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start26 Aug 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie N. Hunt, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058650
- Sponsor's protocol ID
- 18-011329
- Other IDs
- NCI-2023-06047, 18-011329
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hunt KN, Conners AL, Gray L, Hruska CB, O'Connor MK. Molecular Breast Imaging Biopsy with a Dual-Detector System. Radiol Imaging Cancer. 2024 Jun;6(4):e230186. doi: 10.1148/rycan.230186.
PubMed 38847615