Recruiting
Early Phase 1

3D Ultrasound

Sponsor:

Mayo Clinic

Code:

NCT05704283

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultrasound Imaging

Study Details

Brief 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.

Conditions

Breast Carcinoma

Study ID

NCT05704283

Start date

Feb 14, 2023

Status verified date

Jun, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Ultrasound Imaging

Undergo 3D-US

Primary outcome measure

  • Lymph node diagnosis by radiologist (benign or malignant) (Aim 2) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Rica Pol

507-422-5118Pol.Hanarica@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Rica Pol

507-422-5118Pol.Hanarica@mayo.edu

Principal Investigator:

Shigao D. Chen, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-15.