Anatomic Stage III Breast Cancer AJCC v8NCT05547347
Safety, Ultrasound Conspicuity, and Migration of Twinkling Markers in Patients With Locally Advanced Breast Cancer
An observational study of Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase I study assesses the safety, ultrasound visibility (conspicuity), and movement from normal position (migration) of the twinkling marker in patients with breast cancer that has spread to the axillary lymph nodes (locally advanced) who will be undergoing neoadjuvant systemic therapy and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage III Breast Cancer AJCC v8, Locally Advanced Breast Carcinoma, Resectable Breast Carcinoma
- What is being tested?
- Magnetic Resonance Imaging, Mammogram and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 30 Nov 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced breast cancer patients undergoing neoadjuvant systemic therapy and surgery with Dr. Piltin at Mayo Clinic.
Who may be able to join
- Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- Surgical management will be determined by the surgeon, who will decide if preoperative I-125 seed localization of the positive node is necessary or if they will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and twinkling marker will be resected. The position of the marker in the lymph node or proximity to the node will be noted from the surgical and pathology documentation.
- Surgery will be performed by one of the surgeons in the Division of Breast and Melanoma Surgical Oncology (Dr. Judy Boughey, Dr. Amy Degnim, Dr. Tina Hieken, Dr. Jeffrey Johnson, Dr. Mary Mrdutt, Dr. Dalliah Black, Dr. Mara Piltin)
- Patients must be able to understand the study procedures and comply with them for the entire length of the study
- No contraception is necessary or required
Who cannot join
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
- Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Phase 1 Study in Patients With Clinically Node-Positive Breast Cancer to Assess the Safety, Ultrasound Conspicuity, and Migration of an Ultrasound Twinkling Marker Obeservedfor Sonographic Targeting (UTMOST TRIAL)
This phase I study assesses the safety, ultrasound visibility (conspicuity), and movement from normal position (migration) of the twinkling marker in patients with breast cancer that has spread to the axillary lymph nodes (locally advanced) who will be undergoing neoadjuvant systemic therapy and surgery. Biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are needed to help guide breast cancer surgery. Twinkling markers are designed to have the same size and shape of conventional biopsy markers, but are made of a radio-opaque material that assists with localization of the marker. The twinkling marker may make it more easily seen with ultrasound at the time of breast cancer surgery as compared to conventional biopsy markers.
Read the detailed description
PRIMARY OBJECTIVE:
- To show that the biologically inert, Food and Drug Administration (FDA)-approved material that comprises the Mayo-developed twinkling marker, either pre-made and sterilized or made immediately before placement, (Patent Application Title: Non-Metallic Ultrasound-Detectable Markers Patent Application No.: 62/903,078, Application Type: Provisional) remains conspicuous under ultrasound after neoadjuvant systemic therapy in patients with clinically node-positive breast cancer.
SECONDARY OBJECTIVE:
- To evaluate the safety and migration of the Mayo-designed twinkling marker in patients during neoadjuvant systemic therapy (NST).
OUTLINE:
Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker throughout the trial. Patients undergo a breast ultrasound during screening, on study, and as clinically indicated. Patient also undergoes a mammogram on study and as clinically indicated as well as a magnetic resonance imaging (MRI) as clinically indicated.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Locally Advanced Breast Carcinoma, Resectable Breast Carcinoma
- Being tested
- Magnetic Resonance Imaging, Mammogram, Ultrasound, Ultrasound-Guided Biopsy, Twinkle marker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging
Undergo MRI
MammogramProcedure or surgery
Undergo a mammogram
UltrasoundProcedure or surgery
Undergo a breast ultrasound
Ultrasound-Guided BiopsyProcedure or surgery
Also called Ultrasound Guided Biopsy
Undergo a percutaneous ultrasound-guided breast clip placement
Twinkle markerDevice
Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker on study.
| Study group | Role | What they receive |
|---|---|---|
| Observational (twinkle marker placement) | Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker throughout the trial. Patients undergo a breast ultrasound during screening, on study, and as clinically indicated. Patient also undergoes a mammogram on study and as clinically indicated as well as a MRI as clinically indicated. Receives: Procedure: Magnetic Resonance Imaging; Procedure: Mammogram; Procedure: Ultrasound; Procedure: Ultrasound-Guided Biopsy; Device: Twinkle marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term efficacy of the twinkling marker
The primary outcome is information on the long-term efficacy of the twinkling marker in humans placed in the lymph nodes of patients undergoing neoadjuvant systemic therapy (NST) for breast cancer. The data will explore the presence/absence of the twinkling artifact associated with the twinkling marker under ultrasound.
Measured: through study completion, an average of 4 months
Secondary outcomes (1)
Determination of safety and migration of the twinkling marker
The secondary outcome is determination of safety and migration of the Mayo-designed twinkling marker in patients after NST. Clinical notes will be reviewed to assess for any complications related to the twinkling marker during NST. Migration will be determined from surgical and pathology documentation.
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start21 Mar 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Why it stopped: Pending biocompatibility testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage III Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine U Lee, M.D., Ph.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547347
- Sponsor's protocol ID
- 22-002857
- Other IDs
- DTP
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Patients With Clinically Node-Positive Breast Cancer to Assess the Safety, Ultrasound Conspicuity, and Migration of an Ultrasound Twinkling Marker Obeservedfor Sonographic Targeting (UTMOST TRIAL)
- ClinicalTrials.gov ID
- NCT05547347
- Acronym / sponsor ID
- 22-002857
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Locally Advanced Breast Carcinoma, Resectable Breast Carcinoma
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Pending biocompatibility testing
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I study assesses the safety, ultrasound visibility (conspicuity), and movement from normal position (migration) of the twinkling marker in patients with breast cancer that has spread to the axillary lymph nodes (locally advanced) who will be undergoing neoadjuvant systemic therapy and surgery. Biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are needed to help guide breast cancer surgery. Twinkling markers are designed to have the same size and shape of conventional biopsy markers, but are made of a radio-opaque material that assists with localization of the marker. The twinkling marker may make it more easily seen with ultrasound at the time of breast cancer surgery as compared to conventional biopsy markers.
Detailed description
PRIMARY OBJECTIVE:
- To show that the biologically inert, Food and Drug Administration (FDA)-approved material that comprises the Mayo-developed twinkling marker, either pre-made and sterilized or made immediately before placement, (Patent Application Title: Non-Metallic Ultrasound-Detectable Markers Patent Application No.: 62/903,078, Application Type: Provisional) remains conspicuous under ultrasound after neoadjuvant systemic therapy in patients with clinically node-positive breast cancer.
SECONDARY OBJECTIVE:
- To evaluate the safety and migration of the Mayo-designed twinkling marker in patients during neoadjuvant systemic therapy (NST).
OUTLINE:
Patients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker throughout the trial. Patients undergo a breast ultrasound during screening, on study, and as clinically indicated. Patient also undergoes a mammogram on study and as clinically indicated as well as a magnetic resonance imaging (MRI) as clinically indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (twinkle marker placement) | – | Procedure: Magnetic Resonance Imaging, Procedure: Mammogram, Procedure: Ultrasound, Procedure: Ultrasound-Guided Biopsy, Device: Twinkle markerPatients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker throughout the trial. Patients undergo a breast ultrasound during screening, on study, and as clinically indicated. Patient also undergoes a mammogram on study and as clinically indicated as well as a MRI as clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced breast cancer patients undergoing neoadjuvant systemic therapy and surgery with Dr. Piltin at Mayo Clinic.
Key inclusion criteria (5 listed)
- Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- Surgical management will be determined by the surgeon, who will decide if preoperative I-125 seed localization of the positive node is necessary or if they will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and twinkling marker will be resected. The position of the marker in the lymph node or proximity to the node will be noted from the surgical and pathology documentation.
- Surgery will be performed by one of the surgeons in the Division of Breast and Melanoma Surgical Oncology (Dr. Judy Boughey, Dr. Amy Degnim, Dr. Tina Hieken, Dr. Jeffrey Johnson, Dr. Mary Mrdutt, Dr. Dalliah Black, Dr. Mara Piltin)
- Patients must be able to understand the study procedures and comply with them for the entire length of the study
- No contraception is necessary or required
Key exclusion criteria (3 listed)
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
- Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR ImagingUndergo MRI | Procedure or surgery | Observational (twinkle marker placement) |
| MammogramUndergo a mammogram | Procedure or surgery | Observational (twinkle marker placement) |
| UltrasoundUndergo a breast ultrasound | Procedure or surgery | Observational (twinkle marker placement) |
| Ultrasound-Guided BiopsyAlso: Ultrasound Guided BiopsyUndergo a percutaneous ultrasound-guided breast clip placement | Procedure or surgery | Observational (twinkle marker placement) |
| Twinkle markerPatients undergo percutaneous ultrasound-guided breast clip placement with a conventional biopsy marker (if not already present) and a twinkling marker on study. | Device | Observational (twinkle marker placement) |
Primary outcome
Long-term efficacy of the twinkling marker
Time frame: through study completion, an average of 4 months
The primary outcome is information on the long-term efficacy of the twinkling marker in humans placed in the lymph nodes of patients undergoing neoadjuvant systemic therapy (NST) for breast cancer. The data will explore the presence/absence of the twinkling artifact associated with the twinkling marker under ultrasound.
1 secondary outcome
Determination of safety and migration of the twinkling marker
Time frame: through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine U Lee, M.D., Ph.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term efficacy of the twinkling marker (time frame: through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.