Breast CancerNCT03718455
Evaluation of Magseed as Localization Device for Biopsy Proven Metastatic Axillary Lymph Nodes
A study testing Axillary Magseed in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Currently, breast cancer patients who are treated with neoadjuvant chemotherapy (NAC) before surgery may have a biopsy clip placed in the lymph node at the time of or shortly after percutaneous biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Axillary Magseed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women 18 years or older
- Neoadjuvant chemotherapy planned prior to surgical excision
- Scheduled for target axillary lymph node dissection including the localized lymph node and sentinel lymph node
Who cannot join
- Pregnant or nursing women
- Allergy to lidocaine or gadolinium
- Contraindication to MRI (i.e. pacemaker)
- Axillary Infection
- Prior axillary radiation
- Known allergy to bone wax, beeswax or propolis
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Evaluation of Magseed as Localization Device for Biopsy Proven Metastatic Axillary Lymph Nodes in Women With Breast Cancer
Currently, breast cancer patients who are treated with neoadjuvant chemotherapy (NAC) before surgery may have a biopsy clip placed in the lymph node at the time of or shortly after percutaneous biopsy. Following 12-20+ weeks of NAC, pre-surgical localization of the sampled axillary lymph node using a radioactive seed can be done up to 5 days prior to surgery. Localization of the sampled lymph node in patients with complete imaging response to NAC can be technically challenging if the biopsy clip is not sonographically visible. This study is designed to see if it is feasible to place a Magseed, which is magnetic seed, into the abnormal node either at the time of fine needle aspiration (FNA) or after NAC, just prior to surgery, and to be able to accurately identify the abnormal node at the time of surgery.
Read the detailed description
Part 1: Ten women with biopsy proven breast cancer and metastasis to an axillary lymph node will have a Magseed placed into the metastatic lymph node AFTER neoadjuvant chemotherapy (NAC) and just prior to surgery. These patients will have a non-contrast enhanced breast MRI development study to evaluate and identify ways to reduce the artifact in the axilla created by the Magseed. Efficacy of the localization with the Magseed will be available within a week of the placement.
Part 2: Ten additional women with biopsy proven breast cancer and metastasis to an axillary lymph node will have a Magseed placed into the metastatic lymph node BEFORE NAC. These patients will have routine contrast enhanced MRIs, mammograms, and ultrasounds before and after NAC to evaluate treatment response.
Seed placement: Once a patient has been identified eligible for the research study and has provided written informed consent the patient will have a Magseed placed into the biopsy proven lymph node. The Magseed delivery system is identical to the investigators' current practice using radioactive seeds. The seed is pre-loaded into the needle and is inserted into the lymph node following local anesthesia with 1% lidocaine. Once the seed is deployed, post procedure seed location is confirmed sonographically and mammographically with tomosynthesis.
MRI: Ten no-charge limited non-contrast breast MRIs for research development purposes are available for this study through the radiology department. Phase 1 participants will enroll in the study after their pre- and post-NAC imaging has already been performed per routine clinical practice. These participants will have a single non-contrast enhanced breast MRI using the investigators' standard non-contrast sequences (axial ideal T1 and T2-weighted, axial Short-TI Inversion Recovery (STIR), and axial 3D vibrant using a dedicated breast coil, FOV 28 cm or to fit the patient size, and an image-thickness/image-increment of 5mm/1mm). A physicist will participate in the scanning of these patients to evaluate the extent of artifact in the axilla and adjacent breast tissue and optimize scanning parameters to reduce this artifact.
Phase 2 participants will enroll in the study prior to NAC and have routine contrast enhanced breast MRIs performed before and after NAC. Clinically indicated MRI scans will be charged to the patient's insurance company as this imaging is standard clinical practice. The MRI protocol will use the investigators' standard clinical sequences (axial ideal T1 and T2-weighted, axial STIR, and axial 3D vibrant using a dedicated breast coil). Once contrast is injected (gadobutrol 10mmol/10mL) 3D vibrant sequences will be obtained four times after contrast injection (FOV 28 cm or to fit the patient size, and an image-thickness/image-increment of 5mm/1mm).
Mammogram: Patients enrolled in the research study will have standard mammographic imaging before and after NAC, which will include both the breast and axilla as per routine clinical protocol.
Ultrasound: Patients enrolled in the research study will have standard sonographic imaging before and after NAC of the breast and axilla as per routine clinical protocol. Post-NAC ultrasound of the axilla will be a supplemental assessment to breast MRI as the Magseed artifact may obscure these findings.
Seed Removal: As per the current practice, patients will have targeted axillary lymph node dissection including both the localized lymph node and sentinel lymph node. Identifying the lymph node containing the Magseed will require the Sentimag handheld probe in the operating room. This device which functions similar to the gamma probe has been approved for an equipment trial starting in August of 2018. Once the lymph node has been excised a specimen radiograph will be obtained to verify removal.
- Conditions
- Breast Cancer
- Being tested
- Axillary Magseed
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary MagseedDevice
The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Axillary Magseed | Experimental | Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization. Receives: Device: Axillary Magseed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if Magseed is a Viable Alternative to Radioactive Seed as a Localization Method for Biopsy Proven Metastatic Breast Carcinoma Following Neoadjuvant Chemotherapy.
The rate of successful placement of the Magseed into the axilla in the radiology department will be measured. Any substantial barriers to placement compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the radiologist and will be reported on a case-by-case basis.
Measured: 2-22 weeks after placement of the Magseed
Assess the Success of Retrieval of the Magseed and Biopsy Proven Metastatic Lymph Node in the Operating Room Compared to the Current Practice With the Radioactive Seed.
The rate of successful retrieval of the Magseed from the axilla in the operating room will be measured. Any substantial barriers to retrieval compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the surgeon and will be reported on a case-by-cases basis.
Measured: 2-22 weeks after placement of the Magseed
Secondary outcomes (1)
Determine the Amount of Artifact Created by the Magseed in the Axilla at MRI and Identify Imaging Optimization to Minimize the Artifact Produced by the Magnetic Clip.
The maximum dimension of the susceptibility artifact will be measured in centimeters with the investigator's current clinical MRI protocols. Additional MRI sequences with susceptibility artifact suppression techniques will be conducted and the maximum dimension of the susceptibility artifact will be measured in centimeters. Differences in these measurements will be analyzed.
Measured: 2-22 weeks after placement of the Magseed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start30 Oct 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: Limited operating room availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization. The Magseed is a FDA approved device for pre-surgical localization and has been recently approved for use in the axilla and for placement longer than 30 days.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Genevieve A. Woodard, Mayo Clinic
- Investigators
- Genevieve A Woodard, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718455
- Sponsor's protocol ID
- 18-004803
- Status last verified
- Sep 2020
- First submitted
- 15 Oct 2018
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Magseed as Localization Device for Biopsy Proven Metastatic Axillary Lymph Nodes in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT03718455
- Acronym / sponsor ID
- 18-004803
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited operating room availability
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, breast cancer patients who are treated with neoadjuvant chemotherapy (NAC) before surgery may have a biopsy clip placed in the lymph node at the time of or shortly after percutaneous biopsy. Following 12-20+ weeks of NAC, pre-surgical localization of the sampled axillary lymph node using a radioactive seed can be done up to 5 days prior to surgery. Localization of the sampled lymph node in patients with complete imaging response to NAC can be technically challenging if the biopsy clip is not sonographically visible. This study is designed to see if it is feasible to place a Magseed, which is magnetic seed, into the abnormal node either at the time of fine needle aspiration (FNA) or after NAC, just prior to surgery, and to be able to accurately identify the abnormal node at the time of surgery.
Detailed description
Part 1: Ten women with biopsy proven breast cancer and metastasis to an axillary lymph node will have a Magseed placed into the metastatic lymph node AFTER neoadjuvant chemotherapy (NAC) and just prior to surgery. These patients will have a non-contrast enhanced breast MRI development study to evaluate and identify ways to reduce the artifact in the axilla created by the Magseed. Efficacy of the localization with the Magseed will be available within a week of the placement.
Part 2: Ten additional women with biopsy proven breast cancer and metastasis to an axillary lymph node will have a Magseed placed into the metastatic lymph node BEFORE NAC. These patients will have routine contrast enhanced MRIs, mammograms, and ultrasounds before and after NAC to evaluate treatment response.
Seed placement: Once a patient has been identified eligible for the research study and has provided written informed consent the patient will have a Magseed placed into the biopsy proven lymph node. The Magseed delivery system is identical to the investigators' current practice using radioactive seeds. The seed is pre-loaded into the needle and is inserted into the lymph node following local anesthesia with 1% lidocaine. Once the seed is deployed, post procedure seed location is confirmed sonographically and mammographically with tomosynthesis.
MRI: Ten no-charge limited non-contrast breast MRIs for research development purposes are available for this study through the radiology department. Phase 1 participants will enroll in the study after their pre- and post-NAC imaging has already been performed per routine clinical practice. These participants will have a single non-contrast enhanced breast MRI using the investigators' standard non-contrast sequences (axial ideal T1 and T2-weighted, axial Short-TI Inversion Recovery (STIR), and axial 3D vibrant using a dedicated breast coil, FOV 28 cm or to fit the patient size, and an image-thickness/image-increment of 5mm/1mm). A physicist will participate in the scanning of these patients to evaluate the extent of artifact in the axilla and adjacent breast tissue and optimize scanning parameters to reduce this artifact.
Phase 2 participants will enroll in the study prior to NAC and have routine contrast enhanced breast MRIs performed before and after NAC. Clinically indicated MRI scans will be charged to the patient's insurance company as this imaging is standard clinical practice. The MRI protocol will use the investigators' standard clinical sequences (axial ideal T1 and T2-weighted, axial STIR, and axial 3D vibrant using a dedicated breast coil). Once contrast is injected (gadobutrol 10mmol/10mL) 3D vibrant sequences will be obtained four times after contrast injection (FOV 28 cm or to fit the patient size, and an image-thickness/image-increment of 5mm/1mm).
Mammogram: Patients enrolled in the research study will have standard mammographic imaging before and after NAC, which will include both the breast and axilla as per routine clinical protocol.
Ultrasound: Patients enrolled in the research study will have standard sonographic imaging before and after NAC of the breast and axilla as per routine clinical protocol. Post-NAC ultrasound of the axilla will be a supplemental assessment to breast MRI as the Magseed artifact may obscure these findings.
Seed Removal: As per the current practice, patients will have targeted axillary lymph node dissection including both the localized lymph node and sentinel lymph node. Identifying the lymph node containing the Magseed will require the Sentimag handheld probe in the operating room. This device which functions similar to the gamma probe has been approved for an equipment trial starting in August of 2018. Once the lymph node has been excised a specimen radiograph will be obtained to verify removal.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization. The Magseed is a FDA approved device for pre-surgical localization and has been recently approved for use in the axilla and for placement longer than 30 days.
| Arm | Type | Receives |
|---|---|---|
| Axillary Magseed | Experimental | Device: Axillary MagseedSingle cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women 18 years or older
- Neoadjuvant chemotherapy planned prior to surgical excision
- Scheduled for target axillary lymph node dissection including the localized lymph node and sentinel lymph node
Key exclusion criteria (6 listed)
- Pregnant or nursing women
- Allergy to lidocaine or gadolinium
- Contraindication to MRI (i.e. pacemaker)
- Axillary Infection
- Prior axillary radiation
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 |
|---|---|---|
| Axillary MagseedThe Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy. | Device | Axillary Magseed |
Primary outcome
Evaluate if Magseed is a Viable Alternative to Radioactive Seed as a Localization Method for Biopsy Proven Metastatic Breast Carcinoma Following Neoadjuvant Chemotherapy.
Time frame: 2-22 weeks after placement of the Magseed
The rate of successful placement of the Magseed into the axilla in the radiology department will be measured. Any substantial barriers to placement compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the radiologist and will be reported on a case-by-case basis.
Assess the Success of Retrieval of the Magseed and Biopsy Proven Metastatic Lymph Node in the Operating Room Compared to the Current Practice With the Radioactive Seed.
Time frame: 2-22 weeks after placement of the Magseed
The rate of successful retrieval of the Magseed from the axilla in the operating room will be measured. Any substantial barriers to retrieval compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the surgeon and will be reported on a case-by-cases basis.
1 secondary outcome
Determine the Amount of Artifact Created by the Magseed in the Axilla at MRI and Identify Imaging Optimization to Minimize the Artifact Produced by the Magnetic Clip.
Time frame: 2-22 weeks after placement of the Magseed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Genevieve A Woodard 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 Axillary Magseed in people with Breast Cancer, 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluate if Magseed is a Viable Alternative to Radioactive Seed as a Localization Method for Biopsy Proven Metastatic Breast Carcinoma Following Neoadjuvant Chemotherapy. (time frame: 2-22 weeks after placement of the Magseed). The study lists 2 primary outcomes in all. 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 5 Oct 2020.