Ultrasound Twinkling Marker for Breast Cancer

Overseen By Breast and Melanoma Surgical Oncology (BSMO) Clinical Research Unit

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Disqualifiers: Drug or alcohol use, others

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors detect markers in lymph nodes for breast cancer patients using an ultrasound method called the "twinkling artifact." It tests whether the new twinkling marker, a type of ultrasound marker, is more visible than standard markers, which sometimes aren't detectable. The trial includes individuals with breast cancer and biopsy-confirmed cancerous lymph nodes in the armpit. Participants must follow the study procedures and collaborate with the medical team throughout the trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance diagnostic techniques for future patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound twinkling marker is safe for imaging lymph nodes?

Research has shown that the twinkling marker is generally safe for patients. One study examined its short-term safety and found it well-tolerated. Another study assessed both its safety and visibility on an ultrasound, showing that the marker remained in place, a positive sign for safety.

The twinkling marker uses a special ultrasound effect to enhance visibility, aiding doctors in locating it during procedures. Although these studies reported no serious side effects, ongoing research aims to confirm long-term safety. Overall, current evidence suggests that the twinkling marker is a safe option for imaging lymph nodes in breast cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound twinkling marker technique for breast cancer because it offers a new way to accurately identify and track cancerous lymph nodes during treatment. Unlike standard imaging techniques, this method uses an optimized marker that can be placed directly into the lymph node, allowing for precise monitoring with ultrasound. This could improve the effectiveness of neoadjuvant systemic therapy by ensuring that the treatment targets the right areas, potentially leading to better surgical outcomes and less invasive procedures.

What evidence suggests that this ultrasound twinkling marker is effective for imaging lymph nodes in breast cancer?

Research has shown that a new ultrasound marker developed by Mayo Clinic might outperform the usual markers used in biopsies for imaging lymph nodes in breast cancer patients. Participants in this trial will receive this new marker, which uses a special ultrasound effect called the "twinkling artifact," enhancing visibility on an ultrasound. This is crucial because standard markers are often missed by ultrasound about 25% of the time. The twinkling marker aims to improve visibility, potentially serving as a better tool for doctors to locate affected lymph nodes. Early studies suggest this marker could assist in guiding surgical decisions by providing clearer images. ^{3 6 7 8 9}

Who Is on the Research Team?

Christine U. Lee, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06999798?aggFilters=status%3A

An Optimized Ultrasound Twinkling Marker for the Imaging ... The Mayo-designed optimized ultrasound twinkling marker may work better than standard biopsy clip marker in imaging lymph nodes in patients with clinically node ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20585970

Clinical Trials This phase II trial studies the performance, including ultrasound visibility, of an optimized ultrasound twinkling marker in imaging lymph nodes in patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11557156/

Breast ultrasound knobology and the ... This review highlights ten key operator-controlled adjustments (including transducer selection, beam focusing, power, depth, gain and time gain compensation, ...

4. ajronline.org ajronline.org/doi/10.2214/AJR.22.28107

Factors Associated With Ultrasound Color Doppler Twinkling ... The purpose of our study was to identify biopsy markers that show actionable twinkling in cadaveric breast and to assess the association of actionable ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10413298/

Using US Twinkling Artifact to Identify Breast Biopsy Markers This brief report describes the feasibility of identifying Q-shaped and cork-shaped markers by their twinkling signatures in the breast and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0301562924001376

Long-Term Ultrasound Twinkling Detectability and Safety ... In particular, a breast biopsy marker made of PMMA has shown short-term safety and twinkling detectability as a biopsy marker in a Phase 0 clinical trial [18].

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05547347

Safety, Ultrasound Conspicuity, and Migration of Twinkling ... This phase I study assesses the safety, ultrasound visibility (conspicuity), and movement from normal position (migration) of the twinkling marker in patients ...

8. clinicaltrial.be clinicaltrial.be/en/details/14667?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Safety, Ultrasound Conspicuity, and Migration of Twinklin... The primary outcome is information on the long-term efficacy of the twinkling marker in humans placed in the lymph nodes of patients undergoing ...

9. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rycan.220168

Using US Twinkling Artifact to Identify Breast Biopsy Markers Readily available color Doppler US depicted the twinkling signatures of B-mode-occult Q-shaped and cork-shaped breast biopsy markers for in vivo identification.