Clinical trial NCT05142787: Magseed Pro(R)/ Sentimag(R) Gen3
Official title: A Prospective, Multi Center, International, Open Label Study of the Use of Magseed Pro(R) Markers and Sentimag(R) Gen3 to Localize Breast Lesions and Suspicious/biopsy-proven Positive Lymph Nodes in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Magseed Pro
Sentimag Gen3
Lead sponsor: Endomagnetics Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-03
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Participant is aged 18 years or older at the time of consent.
* Patients requiring breast lesion/axillary node marking and excision

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.

* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results
* Known hypersensitivity to Nitinol
* Subject has current active infection at the implantation site in the breast (per investigator discretion)

Primary outcomes:
measure: 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
timeFrame: time of surgery
Secondary outcomes:
measure: Tissue response (unexpected and expected)
timeFrame: time of surgery
measure: Presence of unexpected histological tissue response for short- and long-term use of Magseed Pro marker
timeFrame: time of surgery
measure: Rate of device-related AE's and SAE's
timeFrame: through study completion, an average of 38 weeks
measure: Retrieval rate for all lesions
timeFrame: time of surgery
measure: Retrieval rate for all nodes
timeFrame: time of surgery
measure: Per lesion retrieval rate for target excised specimens
timeFrame: time of surgery
measure: Per lesion retrieval rate for all excised specimens
timeFrame: time of surgery
measure: Per lesion retrieval rate for all lesion
timeFrame: time of surgery
measure: Per lesion retrieval rate for all nodes
timeFrame: time of surgery
measure: Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy
timeFrame: time of surgery
measure: Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy.
timeFrame: time of surgery
measure: Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement.
timeFrame: time of surgery
measure: Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement.
timeFrame: time of surgery
measure: Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement
timeFrame: time of surgery
measure: Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement.
timeFrame: time of surgery
measure: 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.
timeFrame: time of surgery
measure: 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.
timeFrame: time of surgery
measure: Per lesion retrieval rate for target lesions where Magtrace® Tracer is present in the region of the target lesion.
timeFrame: time of surgery
measure: Per lesion retrieval rate for all lesions where Magtrace® Tracer is present in the region of the lesion.
timeFrame: time of surgery
measure: Per node retrieval rate for target nodes where Magtrace® Tracer is present in the target node.
timeFrame: time of surgery
measure: Per node retrieval rate for all nodes where Magtrace® Tracer is present in the node.
timeFrame: time of surgery
measure: Interventionist rated ease of Magseed Pro® marker placement by the interventionist
timeFrame: seed placement
measure: Rate of deployment failure
timeFrame: seed placement
measure: Surgeon rated ease of intra-operative localisation
timeFrame: time of surgery
measure: Magtrace® Tracer counts for excised lymph nodes during SLNB procedures
timeFrame: time of surgery
measure: Re-excision rate (i.e., second procedure required). With reason for second procedure.
timeFrame: time of surgery
measure: Success rate of maintained marker position at the time of removal as determined by specimen X-ray and or Sentimag Gen3 system.
timeFrame: time of surgery
Other outcomes:
Locations:
city: Bottrop
country: Germany
facility: Marienhospital Bottrop GmbH
city: Frankfurt
country: Germany
facility: AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH
city: Munich
country: Germany
facility: Technical University Munich
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: University Hospital South Manchester
Study officials:
affiliation: The technical university of Munich
name: Stefan Paepke, Dr
role: PRINCIPAL_INVESTIGATOR
References: