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

Last updated: January 13, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer/tumors

Carcinoma

Treatment

Ultrasound Imaging

Clinical Study ID

NCT05704283
22-006606
NCI-2023-00106
P30CA015083
R01EB031040
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with lymph node biopsy or lymph node clip placement as per routine clinicalcare.

  • Age of 18 or older.

Exclusion

Exclusion Criteria:

  • Vulnerable subjects such as prisoners and adults lacking capacity to consent.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Ultrasound Imaging
Phase: 1
Study Start date:
February 14, 2023
Estimated Completion Date:
June 01, 2027

Study 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 lymph nodes in patients.

III. Compare the performance of the new 3D-US method with conventional two-dimensional (2D)-US for localizing the clipped lymph nodes.

OUTLINE:

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

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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