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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Endomagnetics Ltd.
- Enrollment
- 224
- Locations
- 6
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
Time Frame: time of surgery
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.
Secondary Outcomes
- Per lesion retrieval rate for all lesion(time of surgery)
- Per lesion retrieval rate for all nodes(time of surgery)
- Per lesion 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 target lesions where Magtrace® Tracer is present in the region of the target lesion.(time of surgery)
- Per node retrieval rate for target nodes where Magtrace® Tracer is present in the target node.(time of surgery)
- Rate of deployment failure(seed placement)
- Retrieval rate for all nodes(time of surgery)
- Per lesion retrieval rate for all excised specimens(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.(time of surgery)
- Per node retrieval rate for all nodes where Magtrace® Tracer is present in the node.(time of surgery)
- Surgeon rated ease of intra-operative localisation(time of surgery)
- Magtrace® Tracer counts for excised lymph nodes during SLNB procedures(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)
- Tissue response (unexpected and expected)(time of surgery)
- Presence of unexpected histological tissue response for short- and long-term use of Magseed Pro marker(time of surgery)
- Re-excision rate (i.e., second procedure required). With reason for second procedure.(time of surgery)
- Rate of device-related AE's and SAE's(through study completion, an average of 38 weeks)
- Retrieval rate for all lesions(time of surgery)
- Per lesion retrieval rate for target excised specimens(time of surgery)
- Per patient 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.(time of surgery)
- 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(time of surgery)
- 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.(time of surgery)
- Per lesion retrieval rate for all lesions where Magtrace® Tracer is present in the region of the lesion.(time of surgery)
- Interventionist rated ease of Magseed Pro® marker placement by the interventionist(seed placement)