Magseed Localization for Breast Cancer

(MAGELLAN Trial)

Recruiting at 2 trial locations

Overseen By Matt Womack, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endomagnetics Inc

Disqualifiers: Distant metastases, Inflammatory breast cancer, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

65 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Magseed Marker, Magseed Marker, Sentimag Marker for breast cancer?

Research shows that the Magseed Marker, used with the Sentimag probe, is effective in accurately locating breast cancer lesions that cannot be felt by hand. This technique has been shown to be reliable and safe in multiple studies, making it a useful tool in breast cancer surgery. ^{1 2 3 4 5}

What makes the Magseed Marker treatment unique for breast cancer?

The Magseed Marker treatment is unique because it involves using a small magnetic seed to precisely locate breast tumors, which helps surgeons remove them more accurately. This method is less invasive and more comfortable for patients compared to traditional wire localization techniques. ^{6 7 8 9 10}

Research Team

Abigail Caudle, MD, MS

Principal Investigator

MD Anderson Cancer Center, Houston, TX

Eligibility Criteria

This trial is for adults over 18 with a specific type of breast cancer that has spread to axillary lymph nodes, and who are planning to have chemotherapy before surgery. They must be in good enough health to undergo the procedure (ECOG 0-2) and not have distant metastases, inflammatory breast cancer, previous similar surgeries or radiation in the area, a history of lymphoma or certain cardiac devices.

Inclusion Criteria

I am eligible for a specific lymph node removal surgery after chemotherapy.

My breast cancer has spread to nearby lymph nodes but not to distant parts of the body.

A clip was placed in my lymph node before starting chemotherapy.

Exclusion Criteria

Subject is pregnant

I have had breast cancer in the same breast before.

I have had surgery on the same side's armpit area before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Magseed Placement

Magseed marker is placed under ultrasound guidance to mark axillary lymph nodes with biopsy-proven metastasis before initiating neo-adjuvant chemotherapy (NAC)

1 week

1 visit (in-person)

Neo-adjuvant Chemotherapy (NAC)

Participants undergo neo-adjuvant chemotherapy

Varies

Surgery

Localized Magseed is removed with the targeted lymph node using the Sentimag system during surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including rates of device-related adverse events

6 weeks

Treatment Details

Interventions

• Magseed Marker

Trial Overview The study tests Magseed/Sentimag's effectiveness for marking and guiding surgical removal of affected axillary lymph nodes in patients after they've had chemotherapy. It aims to provide evidence on whether this method is successful for long-term localization during targeted dissection.

Participant Groups

Group I: Magseed marker Experimental Treatment 1 Intervention

Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.

Magseed Marker is already approved in European Union, United Kingdom, United States for the following indications:

Approved in European Union as Magseed Marker for:

• Breast cancer
• Axillary lymph node localization

Approved in United Kingdom as Magseed Marker for:

• Impalpable breast cancer lesions
• Axillary lymph node localization

Approved in United States as Magseed Marker for:

• Breast cancer
• Axillary lymph node localization

Who Is Running the Clinical Trial?

Endomagnetics Inc

Lead Sponsor

Trials

5

Recruited

560+

Endomagnetics Ltd.

Lead Sponsor

Trials

5

Recruited

520+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Findings from Research

The Magseed magnetic marker technique is a promising and safe method for localizing solitary intra-abdominal metastases, allowing for complete and curative surgical resections in all five patients studied, with only one minor wound infection reported.

This technique improves the visualization of lesions that are not visible or palpable, potentially leading to more precise surgeries and better clinical outcomes by preventing unnecessary removal of healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel labeling modality of intra-abdominal lesions with Magseed magnetic marker and extirpation by Sentimag probe navigation. Toman, D., Sengul, I., Kubala, O., et al.[2023]

In a study involving 39 patients and 41 Magseed implants for breast cancer surgery, the Magseed magnetic marker demonstrated 100% retrieval success and no placement failures, indicating high reliability for tumor localization.

The use of Magseed resulted in negative surgical margins in 85.3% of breast tumor localizations, showing its efficacy in achieving oncosurgical radicality comparable to traditional localization methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Seed (Magseed) Localisation in Breast Cancer Surgery: A Multicentre Clinical Trial. Žatecký, J., Kubala, O., Coufal, O., et al.[2022]

The Magseed localisation technique for non-palpable breast lesions is safe and effective, with a re-excision rate of 14.8%, which is lower than the national average, indicating good surgical outcomes.

In a study involving 137 patients and 139 procedures, the majority of seeds were successfully placed under ultrasound guidance, demonstrating the technique's practicality and efficiency in utilizing surgical resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, single-arm, multicentre clinical evaluation of a new localisation technique using non-radioactive Magseeds for surgery of clinically occult breast lesions. Thekkinkattil, D., Kaushik, M., Hoosein, MM., et al.[2020]

The Sentimag technology for localizing impalpable breast lesions using Magseeds and Magtrace is a safe and reliable alternative to traditional methods, as demonstrated in a preliminary study of 13 patients with no significant adverse outcomes.

The re-excision rate of 23% was slightly higher than typical rates, but this is expected to decrease as the surgeon gains more experience with the technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A series of the first 13 combined Magseed and Magtrace cases in a single centre in regional Victoria. Henegan, J., Wynn, J., Bollard, R.[2023]

The Sentimag device, used for locating breast lesions and sentinel lymph nodes, demonstrated a significantly higher detection rate of two or more sentinel nodes (91%) compared to traditional methods (71.8%), indicating its efficacy in improving surgical outcomes.

The use of the Sentimag system was found to be safe and cost-effective in a rural hospital setting, simplifying care for both patients and surgeons without increasing complication or cancer detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing SentiMag in a rural setting: a 5-year experience. Sreedhar, S., Maloney, J., Hudson, S.[2021]

The novel gene MAG-1 enhances lung cancer cell behaviors associated with metastasis, such as increased cell adhesion to the extracellular matrix, invasion, and proliferation, indicating its potential role in promoting tumor spread.

Analysis of lung cancer tissues revealed that MAG-1 mRNA was significantly more expressed in metastatic patients compared to non-metastatic patients, suggesting that MAG-1 could serve as a biomarker for lung cancer metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Promotion of MAG-1 on Metastasis of Lung Cancer Cells in vitro and Its Expression in Lung Cancer Tissue of 24 Cases.]. Zhang, J., Meng, Y., Lin, H., et al.[2010]

MAGEC2 expression is significantly higher in metastatic breast cancer compared to non-metastatic cases and is associated with poorer patient outcomes, including shorter metastasis-free intervals and overall survival.

Overexpression of MAGEC2 in breast cancer cells enhances their migratory and invasive abilities by promoting epithelial-mesenchymal transition, suggesting that targeting MAGEC2 could be a promising therapeutic strategy for treating breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAGEC2, an epithelial-mesenchymal transition inducer, is associated with breast cancer metastasis. Yang, F., Zhou, X., Miao, X., et al.[2021]

In a study of 49 medullary breast cancer patients, the cancer/testis antigens MAGE-A1, MAGE-A, and NY-ESO-1 were expressed in 33%, 33%, and 22% of tumor samples, respectively, indicating their presence in a significant portion of cases.

Patients with MAGE-A-positive tumors had a significantly lower overall survival compared to those without MAGE-A expression, suggesting that these antigens may serve as important prognostic markers in medullary breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression of MAGE-A and NY-ESO-1 cancer/testis antigens in medullary breast cancer: retrospective immunohistochemical study. Matković, B., Juretić, A., Spagnoli, GC., et al.[2021]

In a study of 177 lymph nodes from 17 breast cancer patients, the markers mammaglobin 1 (MGB1) and mammaglobin B (MGB2) were found to be highly effective for detecting micrometastases, showing 100% positivity in HE-positive lymph nodes.

The combination of MGB1 and MGB2 is suggested as a reliable method for identifying micrometastases in axillary lymph nodes, outperforming other markers like CEA and PSA, which had lower positivity rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selection of mRNA markers for detection of lymph node micrometastases in breast cancer patients. Ooka, M., Sakita, I., Fujiwara, Y., et al.[2019]

In a study of 32 patients with early-stage non-small cell lung cancer (NSCLC), 37% had disseminated tumor cells in their lymph nodes that expressed MAGE-A, suggesting a potential target for immunotherapy.

The detection of these MAGE-A expressing tumor cells could help identify patients who may benefit from adjuvant anti-MAGE-A immunotherapies after surgical resection of NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression of melanoma-antigen-A (MAGE-A) in disseminated tumor cells in regional lymph nodes of patients with operable non-small cell lung cancer. Dango, S., Wang, XT., Gold, M., et al.[2011]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

A novel labeling modality of intra-abdominal lesions with Magseed magnetic marker and extirpation by Sentimag probe navigation. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic Seed (Magseed) Localisation in Breast Cancer Surgery: A Multicentre Clinical Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A prospective, single-arm, multicentre clinical evaluation of a new localisation technique using non-radioactive Magseeds for surgery of clinically occult breast lesions. [2020]

4. Australia pubmed.ncbi.nlm.nih.gov

A series of the first 13 combined Magseed and Magtrace cases in a single centre in regional Victoria. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Introducing SentiMag in a rural setting: a 5-year experience. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Promotion of MAG-1 on Metastasis of Lung Cancer Cells in vitro and Its Expression in Lung Cancer Tissue of 24 Cases.]. [2010]

7. Netherlands pubmed.ncbi.nlm.nih.gov

MAGEC2, an epithelial-mesenchymal transition inducer, is associated with breast cancer metastasis. [2021]

8. Croatia pubmed.ncbi.nlm.nih.gov

Expression of MAGE-A and NY-ESO-1 cancer/testis antigens in medullary breast cancer: retrospective immunohistochemical study. [2021]

9. Greece pubmed.ncbi.nlm.nih.gov

Selection of mRNA markers for detection of lymph node micrometastases in breast cancer patients. [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

Expression of melanoma-antigen-A (MAGE-A) in disseminated tumor cells in regional lymph nodes of patients with operable non-small cell lung cancer. [2011]