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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-06047 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18-011329 | Other Identifier | Mayo Clinic in Rochester |
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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.
PRIMARY OBJECTIVE:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I (technetium Tc-99m sestamibi, MBI) | Experimental | Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy of Breast | Procedure | Undergo biopsy of breast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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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:
PART II: Individuals who have agreed to participate in the study and who have signed study-specific informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katie N. Hunt, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38847615 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017256 | Technetium Tc 99m Sestamibi |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
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| Medical Device Usage and Evaluation | Other | Utilization of the Stereo Navigator accessory |
|
| Scintimammography | Radiation | Undergo MBI |
|
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| Technetium Tc-99m Sestamibi | Other | Given IV |
|
|
| 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. | Baseline; Up to 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |