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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-04853 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| R03CA241020 | U.S. NIH Grant/Contract | View source | |
| 21-002713 | Other Identifier | Mayo Clinic Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.
PRIMARY OBJECTIVES:
I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.
OUTLINE:
Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (ultrasound microvessel imaging) | Experimental | Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Medical record reviewed |
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| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound diagnostic accuracy using McNemar's test | Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test. | Up to 1 year |
| Ultrasound parameters sensitivity using McNemar's test | Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score. | Up to 1 year |
| Ultrasound parameters specificity using McNemar's test | Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year |
| Ultrasound parameters positive predictive value using McNemar's test | Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year |
| Ultrasound parameters negative predictive value using McNemar's test | Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. . | Up to 1 year |
| Ultrasound parameters accuracy using McNemar's test | Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigao Chen, Ph.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2023 | Jun 3, 2024 | ICF_000.pdf |
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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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| Ultrasound Microvessel Imaging | Procedure | Undergo 3D ultrasound microvessel imaging |
|
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| Ultrasound parameters calculated by McNemar's test |
Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. |
| Up to 1 year |
| Ultrasound parameters vs. Breast Image Reporting using McNemar's test | Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |