Ultrasound Twinkling Marker for Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Drug or alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the performance, including ultrasound visibility, of an optimized ultrasound twinkling marker in imaging lymph nodes in patients with clinically node-positive breast cancer. In patients with biopsy-proven breast cancer, biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are critical for guiding surgical management many months after the marker is placed. For breast radiologists and breast surgeons, there is a need for simple, consistent visibility of biopsy markers by ultrasound, particularly several months after marker placement. Ultrasound is the imaging method of choice, particularly for lymph nodes in the armpit (axilla). Ultrasound is non-ionizing and is more comfortable for patients compared to mammography. However, ultrasound visibility of these markers is challenging and inconsistent, with ultrasound failing to detect the marker approximately 25% of the time. The Mayo-designed investigational biopsy marker takes advantage of an ultrasound phenomenon called twinkling artifact. The Mayo-designed optimized ultrasound twinkling marker may work better than standard biopsy clip marker in imaging lymph nodes in patients with clinically node-positive breast cancer.

Research Team

Christine U. Lee, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Matthew W. Urban, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for patients with clinically node-positive breast cancer. It's designed to test a new type of ultrasound marker that could be easier to see on scans months after placement, which is important for guiding surgery.

Inclusion Criteria

No contraception is necessary or required

My surgery will be decided by a specialized surgeon.

I am over 18 with breast cancer and a biopsy showing cancer in my underarm lymph node.

Exclusion Criteria

Current drug or alcohol use or dependence that would interfere with adherence to study requirements

Inability or unwillingness to give written informed consent

Current or past participation within a specified timeframe in another clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Marker Placement and Imaging

Patients undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node, followed by additional ultrasound imaging and SOC mammography prior to starting NST.

Baseline up to 6-9 months

Multiple visits for imaging and marker placement

Neoadjuvant Systemic Therapy (NST)

Optional ultrasound imaging during NST as clinically indicated.

6-9 months

Surgery

Surgical removal of the optimized twinkling marker during SOC surgical resection of the positive lymph node.

At time of surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

Treatment Details

Interventions

• Twinkling Marker

Trial Overview The UTMOST2 trial is evaluating an optimized ultrasound twinkling marker against standard biopsy clip markers. The focus is on the visibility and performance of these markers in imaging lymph nodes during ultrasounds.

Participant Groups

Group I: Diagnostic (optimized twinkling marker placement, ultrasound) Experimental Treatment 4 Interventions

Patients undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node, followed by additional ultrasound imaging and SOC mammography prior to starting NST. Patients also undergo optional ultrasound imaging during NST as clinically indicated. Patients then undergo surgical removal of the optimized twinkling marker during SOC surgical resection of the positive lymph node.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+