Breast Neoplasm FemaleNCT04674852
Mayo Designed Soft Tissue Ultrasound-Detectable Marker
A study testing Research Marker in people with Breast Neoplasm Female and Ultrasound Therapy; Complications, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Ultrasound Therapy; Complications
- What is being tested?
- Research Marker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 7 Apr 2022
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
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 involves preoperative radioactive seed localization of a previously identified positive axillary lymph node
- Surgery will be performed by Dr. James Jakub at Mayo Clinic Rochester, MN
- Radioactive seed localization of an axillary lymph node.
- No contraception is necessary or required.
- English speaking
Who cannot join
- Scheduled for only radioactive seed localizations in the breast (as opposed to axilla)
- Are pregnant; although the twinkling marker is made of material widely used in orthopedic procedures, and hence, has an excellent safety profile, the investigators want to exclude the population of pregnant patients in this phase 0 clinical trial.
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 Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer
Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.
Read the detailed description
Nonrandomized clinical trial to evaluate the Mayo-designed marker for ultrasound conspicuity at the time of preoperative ultrasound-guided localization.
Study participants are breast cancer patients with pathology-proven metastatic axillary lymph nodes. Per standard of care, a biopsy marker will have already been associated with the positive lymph node. 10 such patients scheduled for surgery at Mayo Clinic Rochester, MN with Dr. James Jakub will be enrolled. Preoperative radioactive seed localization will proceed as usual, but the marker will be additionally loaded with the seed into the needle using standard protocol. Before surgery, ultrasound will be performed to evaluate the marker.
- Being tested
- Research Marker
- Keywords
- axillary lymph node, biopsy clip, biopsy marker, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research MarkerDevice
The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Marking cN+ nodes | Other | These patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed. Receives: Device: Research Marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound detectability
Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.
Measured: Time of placement to surgical resection.
Secondary outcomes (1)
Conspicuity compared to conventional biopsy markers and radioactive seeds
To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds.
Measured: Time of placement to surgical resection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start2 Nov 2020
- Primary completion26 Jul 2021
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine U. Lee, Mayo Clinic
- Investigators
- Christine Lee, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674852
- Sponsor's protocol ID
- 20-002505
- Status last verified
- Jan 2023
- First submitted
- 14 Dec 2020
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jakub JW, Hesley GK, Larson NB, Yaszemski MJ, Lee Miller A 2nd, Greenleaf JF, Urban MW, Lee CU. Ultrasonographic Detection and Surgical Retrieval of a Nonmetallic Twinkle Marker in Breast Cancer: Pilot Study. Radiol Imaging Cancer. 2022 Nov;4(6):e220053. doi: 10.1148/rycan.220053.
PubMed 36367449
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer
- ClinicalTrials.gov ID
- NCT04674852
- Acronym / sponsor ID
- 20-002505
- Keywords
- axillary lymph node, biopsy clip, biopsy marker, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 19 Dec 2020 (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.
Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.
Detailed description
Nonrandomized clinical trial to evaluate the Mayo-designed marker for ultrasound conspicuity at the time of preoperative ultrasound-guided localization.
Study participants are breast cancer patients with pathology-proven metastatic axillary lymph nodes. Per standard of care, a biopsy marker will have already been associated with the positive lymph node. 10 such patients scheduled for surgery at Mayo Clinic Rochester, MN with Dr. James Jakub will be enrolled. Preoperative radioactive seed localization will proceed as usual, but the marker will be additionally loaded with the seed into the needle using standard protocol. Before surgery, ultrasound will be performed to evaluate the marker.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marking cN+ nodes | Other | Device: Research MarkerThese patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- Surgical management involves preoperative radioactive seed localization of a previously identified positive axillary lymph node
- Surgery will be performed by Dr. James Jakub at Mayo Clinic Rochester, MN
- Radioactive seed localization of an axillary lymph node.
- No contraception is necessary or required.
Key exclusion criteria (2 listed)
- Scheduled for only radioactive seed localizations in the breast (as opposed to axilla)
- Are pregnant; although the twinkling marker is made of material widely used in orthopedic procedures, and hence, has an excellent safety profile, the investigators want to exclude the population of pregnant patients in this phase 0 clinical trial.
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 |
|---|---|---|
| Research MarkerThe research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound. | Device | Marking cN+ nodes |
Primary outcome
Ultrasound detectability
Time frame: Time of placement to surgical resection.
Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.
1 secondary outcome
Conspicuity compared to conventional biopsy markers and radioactive seeds
Time frame: Time of placement to surgical resection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Derived from this study: PubMed 36367449Jakub JW, Hesley GK, Larson NB, Yaszemski MJ, Lee Miller A 2nd, Greenleaf JF, Urban MW, Lee CU. Ultrasonographic Detection and Surgical Retrieval of a Nonmetallic Twinkle Marker in Breast Cancer: Pilot Study. Radiol Imaging Cancer. 2022 Nov;4(6):e220053. doi: 10.1148/rycan.220053.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Lee, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research Marker in people with Breast Neoplasm Female and Ultrasound Therapy; Complications, 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultrasound detectability (time frame: Time of placement to surgical resection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674852, which also lists 1 linked publication.
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 20 Jan 2023.