1. 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 outcome:
1. Tissue response (unexpected and expected) (Time Frame - time of surgery): 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
2. Presence of unexpected histological tissue response for short- and long-term use of Magseed Pro marker (Time Frame - time of surgery): 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
3. Rate of device-related AE's and SAE's (Time Frame - through study completion, an average of 38 weeks): Rate of device-related AE's and SAE's
4. Retrieval rate for all lesions (Time Frame - time of surgery): 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.
5. Retrieval rate for all nodes (Time Frame - time of surgery): 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.
6. Per lesion retrieval rate for target excised specimens (Time Frame - time of surgery): Per lesion retrieval rate for target excised specimens
7. Per lesion retrieval rate for all excised specimens (Time Frame - time of surgery): Per lesion retrieval rate for all excised specimens
8. Per lesion retrieval rate for all lesion (Time Frame - time of surgery): Per lesion retrieval rate for all lesion
9. Per lesion retrieval rate for all nodes (Time Frame - time of surgery): Per lesion retrieval rate for all nodes
10. Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy (Time Frame - time of surgery): Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy
11. Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy. (Time Frame - time of surgery): Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy.
12. Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement. (Time Frame - time of surgery): Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement.
13. Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement. (Time Frame - time of surgery): Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement.
14. Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement (Time Frame - time of surgery): Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement
15. Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement. (Time Frame - time of surgery): Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement.
16. 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 Frame - 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.
17. 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 Frame - 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.
18. Per lesion retrieval rate for target lesions where Magtrace® Tracer is present in the region of the target lesion. (Time Frame - time of surgery): Per lesion retrieval rate for target lesions where Magtrace® Tracer is present in the region of the target lesion.
19. Per lesion retrieval rate for all lesions where Magtrace® Tracer is present in the region of the lesion. (Time Frame - time of surgery): Per lesion retrieval rate for all lesions where Magtrace® Tracer is present in the region of the lesion.
20. Per node retrieval rate for target nodes where Magtrace® Tracer is present in the target node. (Time Frame - time of surgery): Per node retrieval rate for target nodes where Magtrace® Tracer is present in the target node.
21. Per node retrieval rate for all nodes where Magtrace® Tracer is present in the node. (Time Frame - time of surgery): er node retrieval rate for all nodes where Magtrace® Tracer is present in the node.
22. Interventionist rated ease of Magseed Pro® marker placement by the interventionist (Time Frame - seed placement): 5 point Likert scale, very easy = 5, very difficult = 1
23. Rate of deployment failure (Time Frame - seed placement): A Magseed Pro is not deployed from the needle, or is accidentally deployed prior to use in the patient
• Success rate of seed placement:
Accurate: Within the breast lesion or clipped lymph node. For lesions less than 5 mm in size the marker may not necessarily be within the excised specimen but should be within 10mm1 of the lesion.
Inadequate: Not in the targeted lesion or clipped lymph node determined by placement imaging requiring additional marker placement
24. Surgeon rated ease of intra-operative localisation (Time Frame - time of surgery): 5 point Likert scalevery easy = 5, very difficult = 1
25. Magtrace® Tracer counts for excised lymph nodes during SLNB procedures (Time Frame - time of surgery): Magtrace® Tracer counts for excised lymph nodes during SLNB procedures
26. Re-excision rate (i.e., second procedure required). With reason for second procedure. (Time Frame - time of surgery): Re-excision rate (i.e., second procedure required). With reason for second procedure.
27. Success rate of maintained marker position at the time of removal as determined by specimen X-ray and or Sentimag Gen3 system. (Time Frame - time of surgery): Accurate: Magseed Pro® marker within the target lesion or marked lymph node.
Inadequate: Magseed Pro® marker not within the target lesion or marked lymph node
Other: axillary lymph nodes requiring localisation prior to surgical excision 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.
Other: breast lesions requiring localisation 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.
Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics: placement of Magseed Pro & localisation with Sentimag Gen3 in axillary lymph nodes and/or breast lesions
Quelle: ClinicalTrials.gov
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