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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called Magseed to help doctors locate lymph nodes in breast cancer patients undergoing chemotherapy before surgery. Magseed, a marker placed in the body, pinpoints the exact spot for surgeons to focus on during a procedure. The trial seeks patients with breast cancer that has spread to the lymph nodes and who are already planning to undergo chemotherapy before surgery. Participants should have a specific type of breast cancer and must have had a marker placed in the lymph node before starting treatment. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance surgical outcomes.

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 prior data suggests that the Magseed Marker is safe for marking axillary lymph nodes?

Research has shown that the Magseed marker is safe for patients. In a recent study with 100 patients, the Magseed accurately located breast lumps that are hard to feel and remained in the correct position. Another study confirmed its effectiveness in marking both non-cancerous and cancerous breast lumps, with no safety issues reported.

Additionally, studies have reported no serious problems related to the device, indicating no major issues linked to using the Magseed in these trials. The Magseed can be detected in breast tissue of all sizes and depths, enhancing its reliability. Overall, evidence suggests that the Magseed marker is well-tolerated and safe for patients undergoing breast cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard breast cancer treatments that typically involve surgical markers made of wires, the Magseed marker offers a wire-free solution. This tiny magnetic seed is deployed percutaneously under ultrasound guidance, making it less invasive and more comfortable for patients. Researchers are excited because it precisely marks a lymph node for selective surgical removal after chemotherapy, potentially enhancing the accuracy and effectiveness of the surgery. This innovative approach could improve patient outcomes by reducing the need for additional surgeries and minimizing tissue disruption.

What evidence suggests that the Magseed Marker is effective for breast cancer?

Research has shown that the Magseed marker system effectively marks and locates breast lumps that can't be felt by touch. In this trial, participants will receive the Magseed marker, deployed percutaneously under ultrasound guidance to mark a lymph node for selective surgical removal post-chemotherapy. One study demonstrated that Magseed successfully marked and helped remove lymph nodes in breast cancer patients after chemotherapy. The system also proved safe, with all markers removed, leaving no material behind in the body. Another large study confirmed that Magseed helps surgeons accurately find and remove targeted tissue before surgery. These findings suggest that Magseed could be a reliable tool for guiding breast cancer surgeries. ^{1 3 4 6 7}

Who Is on the Research Team?

Abigail Caudle, MD, MS

Principal Investigator

MD Anderson Cancer Center, Houston, TX

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8130552/

Effectiveness and Safety of Magseed Localization for ... Conclusions: The Magseed system for localization of nonpalpable lesions was effective and safe; all markers were successfully retrieved with margin-negative ...

2. gs.amegroups.org gs.amegroups.org/article/view/112648/html

Clinical experience of the Magseed® magnetic marker to ... The aim of this study was to report on a cohort of 100 patients where the Magseed paramagnetic marker was used to localize non-palpable breast lesions.

3. endomag.com endomag.com/resources/clinical-data/seeds/

Magseed® Clinical Data This study shows that Magseed is highly effective for marking and selectively removing axillary lymph nodes in breast cancer patients after neoadjuvant ...

4. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(23)00211-2/fulltext

Magnetic Localization of Breast Lesions: A Large-Scale ... The aim of our study is to evaluate on a large scale the performance of preoperative magnetic seed localization of nonpalpable breast lesions.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05142787

NCT05142787 | Magseed Pro(R)/ Sentimag(R) Gen3 The purpose of this study is to provide prospective evidence that the Magseed Pro® marker /Sentimag® Gen3 system is safe and effective for marking A. suspicious ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10240439/

Clinical experience of the Magseed® magnetic marker to ... The aim of this study was to report on a cohort of 100 patients where the Magseed paramagnetic marker was used to localize non-palpable breast lesions.

7. ejso.com ejso.com/article/S0748-7983(24)01077-1/fulltext

A prospective multicentre open label study of Magseed Pro ... The safety endpoint was the rate of device-related adverse events and secondary endpoints include rate of failure of deployment, re-excision rate, rate of ...