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

NCT ID: NCT05704283

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (3D-US)

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.

Group Type EXPERIMENTAL

Ultrasound Imaging

Intervention Type DEVICE

Undergo 3D-US

Interventions

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Ultrasound Imaging

Undergo 3D-US

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Patients with lymph node biopsy or lymph node clip placement as per routine clinical care.
* Age of 18 or older.

Exclusion Criteria

* Vulnerable subjects such as prisoners and adults lacking capacity to consent.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shigao D Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

Phone: 855-776-0015

Email: [email protected]

Rica Pol

Role: CONTACT

Phone: 507-422-5118

Email: [email protected]

Facility Contacts

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Clinical Trials Referral Office

Role: primary

Rica Pol

Role: backup

Related Links

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Other Identifiers

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NCI-2023-00106

Identifier Type: REGISTRY

Identifier Source: secondary_id

R01EB031040

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-006606

Identifier Type: -

Identifier Source: org_study_id