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

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05704283
Collaborator
National Cancer Institute (NCI) (NIH)
60
Enrollment
1
Location
1
Arm
25
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound Imaging
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. Conducting a pilot study to optimize the in vivo performance of the newly developed three-dimensional (3D)-ultrasound (US) technology.

  2. Evaluate the performance of the new 3D-US technique in differentiating benign from malignant axillary lymph nodes (ALNs).

  3. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
3D Ultrasound Imaging of the Axillary Lymph Nodes
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

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
Undergo 3D-US
Other Names:
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasonography
  • Ultrasound
  • Ultrasound Test
  • Ultrasound, Medical
  • US

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Axillary lymph node (ALN) diagnosis by radiologist (benign or malignant) (Aim 2) [Up to 2 years]

      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.

    Eligibility Criteria

    Criteria

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

    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:
    Shiago Chen, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05704283
    Other Study ID Numbers:
    • 22-006606
    • NCI-2023-00106
    • P30CA015083
    First Posted:
    Jan 30, 2023
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    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 Jan 30, 2023