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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/biopsy-proven positive axillary lymph nodes; and B. soft tissue lesions including cancer and pre-cancerous change in the breast
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/biopsy-proven positive axillary lymph nodes; and B. soft tissue lesions including cancer and pre-cancerous change in the breast The devices used in this clinical trial are the Magseed Pro® marker and Sentimag® Gen3 system by Endomagnetics Limited.
The Endomag Magseed Pro® Marker System is intended to be placed within the target soft tissue prior to planned surgical removal. The marker, when used in conjunction with the Sentimag® Gen 3 System, can be used as a guide for the surgeon to follow in the excision of tissue. The Sentimag® Gen3 Magnetic Localisation System when used with the Magseed family of markers is indicated to assist in localising soft tissue lesions.
The study design is a multicentre international prospective, open label, study of Magseed Pro® marker and Sentimag® Gen3 system in patients with breast and/or lymph node pathology with:
A. axillary lymph nodes requiring localisation prior to surgical excision (suspicious and/or biopsy proven lymph node or other pathology indicating removal) and/or B. breast lesions requiring localisation
Patients will have the Magseed Pro® marker placed to mark A. surgical excision of suspicious/biopsy-proven axillary lymph node as part of a targeted lymph node biopsy procedure AND/OR B. breast lesions in patients undergoing surgical excision of the targeted breast lesion The Magseed Pro® marker will be localised using the Sentimag® Gen3 system and therafter surgically removed with the target tissue.
This study will enrol 224 patients; 112 with Magseed Pro® marker placed to mark breast lesions and 112 with Magseed Pro® marker placed to mark nodes.
The expected duration of enrolment is approximately 9 months across all sites with each individual subject's participation lasting approximately 1-38 weeks after enrolment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| axillary lymph nodes requiring localisation prior to surgical excision | Other | The Magseed Pro® marker is intended to be placed percutaneously in suspicious/biopsy proven positive axillary lymph nodes under imaging guidance to mark tissue intended for selective surgical removal. The Magseed Pro® marker is localised using the Sentimag® Gen3 system handheld probes and surgically removed within/from the target tissue. |
|
| breast lesions requiring localisation | Other | The Magseed Pro® marker is intended to be placed percutaneously in breast lesions under imaging guidance to mark tissue intended for selective surgical removal. The Magseed Pro® marker is localised using the Sentimag® Gen3 system handheld probes and surgically removed within/from the target tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics | Device | placement of Magseed Pro & localisation with Sentimag Gen3 in axillary lymph nodes and/or breast lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoints are the retrieval rates of the Magseed Pro® marker with the target lesion within the initial excised specimen for A.) axillary lymph nodes B.) breast lesions A.) axillary lymph nodes. B.) breast lesions | This is defined as the number of patients with successful Magseed Pro® marker placement as demonstrated on imaging, in whom the Magseed Pro® marker and the associated lymph node and/ or lesion is retrieved, divided by the total number of subjects. | time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue response (unexpected and expected) | EXPECTED Early (up to 2 days) - acute inflammation in the form of neutrophils with lymphocytes and some associated haemorrhage. Late (>2 days) - active chronic inflammation in the form of neutrophils, lymphocytes, macrophages together with a fibroblastic response. Likely a foreign body reaction with increased numbers of histiocytes and some multinucleated giant cells. Possible granuloma formation (foreign body type). Scattered eosinophils. Later scarring (after 1-2 weeks) with fibrosis. Possible fat necrosis. UNEXPECTED Early and Late - • Very florid fibroblastic response with granulation tissue formation that mimics malignancy (nodular fasciitis-like), which may need immunohistochemical tests to differentiate between reactive chan |
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Inclusion Criteria:
Exclusion Criteria:• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. A pregnancy test is required for all women of childbearing potential within 7 days before enrolment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matt Womack, Dr | Contact | +447851247439 | mwomack@endomag.com | |
| Tanja Odeneg, Dr | Contact | +441223652604 | todeneg@endomag.com |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Paepke, Dr | The technical university of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marienhospital Bottrop GmbH | Recruiting | Bottrop | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| time of surgery |
| Presence of unexpected histological tissue response for short- and long-term use of Magseed Pro marker | UNEXPECTED HISTOLOGICAL RESPONSE Early and Late - • Very florid fibroblastic response with granulation tissue formation that mimics malignancy (nodular fasciitis-like), which may need immunohistochemical tests to differentiate between reactive chan | time of surgery |
| Rate of device-related AE's and SAE's | Rate of device-related AE's and SAE's | through study completion, an average of 38 weeks |
| Retrieval rate for all lesions | Retrieval rate for all lesions (including target, non-target lesions and multiple lesions per patient) out of the total number of lesions with a Magseed Pro® marker placement. Non-target lesions include additional marked lesions which weren't defined as the target for the primary endpoint and any marked lesions from patients undergoing long term node retrieval. | time of surgery |
| Retrieval rate for all nodes | Retrieval rate for all nodes (including multiple nodes per patient where applicable) out of the total number of nodes with a Magseed Pro® marker placement. | time of surgery |
| Per lesion retrieval rate for target excised specimens | Per lesion retrieval rate for target excised specimens | time of surgery |
| Per lesion retrieval rate for all excised specimens | Per lesion retrieval rate for all excised specimens | time of surgery |
| Per lesion retrieval rate for all lesion | Per lesion retrieval rate for all lesion | time of surgery |
| Per lesion retrieval rate for all nodes | Per lesion retrieval rate for all nodes | time of surgery |
| Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy | Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy | time of surgery |
| Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy. | Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy. | time of surgery |
| Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement. | Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement. | time of surgery |
| Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement. | Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement. | time of surgery |
| Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement | Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement | time of surgery |
| Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement. | Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement. | time of surgery |
| Per lesion retrieval rate for target excised specimens (i.e., lesions plus nodes) where Magtrace® Tracer is present in the target node or in the region of the target lesion. | Per lesion retrieval rate for target excised specimens (i.e., lesions plus nodes) where Magtrace® Tracer is present in the target node or in the region of the target lesion. | time of surgery |
| Per lesion retrieval rate for all excised specimens (i.e., lesions plus nodes) where Magtrace® Tracer is present in the target node or in the region of the target lesion. | Per lesion retrieval rate for all excised specimens (i.e., lesions plus nodes) where Magtrace® Tracer is present in the target node or in the region of the target lesion. | time of surgery |
| Per lesion retrieval rate for target lesions where Magtrace® Tracer is present in the region of the target lesion. | Per lesion retrieval rate for target lesions where Magtrace® Tracer is present in the region of the target lesion. | time of surgery |
| Per lesion retrieval rate for all lesions where Magtrace® Tracer is present in the region of the lesion. | Per lesion retrieval rate for all lesions where Magtrace® Tracer is present in the region of the lesion. | time of surgery |
| Per node retrieval rate for target nodes where Magtrace® Tracer is present in the target node. | Per node retrieval rate for target nodes where Magtrace® Tracer is present in the target node. | time of surgery |
| Per node retrieval rate for all nodes where Magtrace® Tracer is present in the node. | er node retrieval rate for all nodes where Magtrace® Tracer is present in the node. | time of surgery |
| Interventionist rated ease of Magseed Pro® marker placement by the interventionist | 5 point Likert scale, very easy = 5, very difficult = 1 | seed placement |
| Rate of deployment failure | A Magseed Pro is not deployed from the needle, or is accidentally deployed prior to use in the patient • Success rate of seed placement:
| seed placement |
| Surgeon rated ease of intra-operative localisation | 5 point Likert scalevery easy = 5, very difficult = 1 | time of surgery |
| Magtrace® Tracer counts for excised lymph nodes during SLNB procedures | Magtrace® Tracer counts for excised lymph nodes during SLNB procedures | time of surgery |
| Re-excision rate (i.e., second procedure required). With reason for second procedure. | Re-excision rate (i.e., second procedure required). With reason for second procedure. | time of surgery |
| Success rate of maintained marker position at the time of removal as determined by specimen X-ray and or Sentimag Gen3 system. |
| time of surgery |
| AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH | Recruiting | Frankfurt | Germany |
|
| Technical University Munich | Not yet recruiting | Munich | Germany |
|
| Guy's Hospital | Recruiting | London | United Kingdom |
|
| Royal Marsden Hospital | Recruiting | London | United Kingdom |
|
| University Hospital South Manchester | Recruiting | Manchester | United Kingdom |
|
| D017437 |
| Skin and Connective Tissue Diseases |