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NCT05704283 | Recruiting | Breast Carcinoma


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

Mayo Clinic

Information provided by (Responsible Party):

shiGaoChen

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.

Condition or disease

Breast Carcinoma

Intervention/treatment

Ultrasound Imaging

Phase

Early Phase 1

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.}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Diagnostic
Official Title : 3D Ultrasound Imaging of the Axillary Lymph Nodes
Actual Study Start Date : February 14, 2023
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025
Arm Intervention/treatment

Experimental: Diagnostic (3D-US)

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.

Device: Ultrasound Imaging

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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.

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

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

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Locations


Recruiting

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

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