3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer

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Primary Purpose

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ultrasound Imaging

About this trial

This is an interventional diagnostic trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female patients with breast cancer and scheduled to have axillary lymph node biopsy as per routine clinical care. Age of 18 or older. Exclusion Criteria: Vulnerable subjects such as prisoners and adults lacking capacity to consent.

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (3D-US)

Arm Description

Patients undergo 3D-US on study. Patients who have an ALN clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.

Outcomes

Primary Outcome Measures

Axillary lymph node (ALN) diagnosis by radiologist (benign or malignant) (Aim 2)

Will characterize the ALN as benign or malignant by reviewing images from each imaging technique based on clinical criteria including node size, shape, margin, cortical thickness, stiffness, and vascularity obtained from B-mode, shear wave elastography, and Doppler imaging. Histopathology results will be used as the ground truth to measure the sensitivity and specificity of each ultrasound technology for distinguishing between benign and malignant ALNs. The overall agreement of the new 3dimensional (D)-ultrasound (US) method with the biopsy result will be compared to that for 2D-US using McNemar's test. For clipped ALNs, the performance of 2D and 3D-US will be compared for localizing the clips. A numerical score system will be used for quantifying the performance of clip localization, with significant improvement in scores determined using the Freeman-Halton extension of the Fisher exact test. In all cases, we will consider two-tailed p < 0.05 as statistically significant.

Secondary Outcome Measures

Full Information

NCT ID

NCT05704283

First Posted

January 19, 2023

Last Updated

March 30, 2023

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05704283

Brief Title

3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer

Official Title

3D Ultrasound Imaging of the Axillary Lymph Nodes

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 14, 2023 (Actual)

Primary Completion Date

April 1, 2025 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

No

5. Study Description

Brief Summary

This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating axillary lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.

Detailed Description

PRIMARY OBJECTIVES: I. Conducting a pilot study to optimize the in vivo performance of the newly developed three-dimensional (3D)-ultrasound (US) technology. II. Evaluate the performance of the new 3D-US technique in differentiating benign from malignant axillary lymph nodes (ALNs). III. Compare the performance of the new 3D-US method with conventional two-dimensional (2D)-US for localizing the clipped ALNs. OUTLINE: Patients undergo 3D-US on study. Patients who have an ALN clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (3D-US)

Arm Type

Experimental

Arm Description

Patients undergo 3D-US on study. Patients who have an ALN clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.

Intervention Type

Device

Intervention Name(s)

Ultrasound Imaging

Other Intervention Name(s)

2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Intervention Description

Undergo 3D-US

Primary Outcome Measure Information:

Title

Axillary lymph node (ALN) diagnosis by radiologist (benign or malignant) (Aim 2)

Description

Will characterize the ALN as benign or malignant by reviewing images from each imaging technique based on clinical criteria including node size, shape, margin, cortical thickness, stiffness, and vascularity obtained from B-mode, shear wave elastography, and Doppler imaging. Histopathology results will be used as the ground truth to measure the sensitivity and specificity of each ultrasound technology for distinguishing between benign and malignant ALNs. The overall agreement of the new 3dimensional (D)-ultrasound (US) method with the biopsy result will be compared to that for 2D-US using McNemar's test. For clipped ALNs, the performance of 2D and 3D-US will be compared for localizing the clips. A numerical score system will be used for quantifying the performance of clip localization, with significant improvement in scores determined using the Freeman-Halton extension of the Fisher exact test. In all cases, we will consider two-tailed p < 0.05 as statistically significant.

Time Frame

Up to 2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Female patients with breast cancer and scheduled to have axillary lymph node biopsy as per routine clinical care. Age of 18 or older. Exclusion Criteria: Vulnerable subjects such as prisoners and adults lacking capacity to consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shigao D Chen

Organizational Affiliation

Mayo Clinic in Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Referral Office

Phone

855-776-0015

Email

mayocliniccancerstudies@mayo.edu

First Name & Middle Initial & Last Name & Degree

Shigao D. Chen, M.D.

Breast Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial