3D Ultrasound Microvessel Imaging for Breast Masses

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04925817
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 32
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma	Other: Electronic Health Record Review; Procedure: Ultrasound Microvessel Imaging	Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 3D Ultrasound Microvessel Imaging for Breast Masses
• Actual Study Start Date: Aug 19, 2021
• Anticipated Primary Completion Date: Apr 20, 2023
• Anticipated Study Completion Date: Apr 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diagnostic (ultrasound microvessel imaging) Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.	Other: Electronic Health Record Review; Medical record reviewed; Procedure: Ultrasound Microvessel Imaging; Undergo 3D ultrasound microvessel imaging

Outcome Measures

Primary Outcome Measures

1. Ultrasound diagnostic accuracy using McNemar's test [Up to 1 year]

   Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.

2. Ultrasound parameters sensitivity using McNemar's test [Up to 1 year]

   Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.

3. Ultrasound parameters specificity using McNemar's test [Up to 1 year]

   Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.

4. Ultrasound parameters positive predictive value using McNemar's test [Up to 1 year]

   Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.

5. Ultrasound parameters negative predictive value using McNemar's test [Up to 1 year]

   Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .

6. Ultrasound parameters accuracy using McNemar's test [Up to 1 year]

   Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.

7. Ultrasound parameters calculated by McNemar's test [Up to 1 year]

   Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.

8. Ultrasound parameters vs. Breast Image Reporting using McNemar's test [Up to 1 year]

   Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.

• Lesion size of 1 cm or larger.

• Age 18 or greater.

Exclusion Criteria:

• Women with previous breast surgery or breast implant.

• Lacking the capacity to consent.

• Women who are pregnant or lactating.

• Women who are receiving cancer therapy such as chemotherapy or radiation therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Shigao D Chen, Mayo Clinic in Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04925817
• Other Study ID Numbers: 21-002713; NCI-2021-04853; 21-002713; P30CA015083
• First Posted: Jun 14, 2021
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of May 13, 2022