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
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
Rate of device-related AE's and SAE's
Rate of device-related AE's and SAE's
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.
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.
Per lesion retrieval rate for target excised specimens
Per lesion retrieval rate for target excised specimens
Per lesion retrieval rate for all excised specimens
Per lesion retrieval rate for all excised specimens
Per lesion retrieval rate for all lesion
Per lesion retrieval rate for all lesion
Per lesion retrieval rate for all nodes
Per lesion retrieval rate for all nodes
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
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
Interventionist rated ease of Magseed Pro® marker placement by the interventionist
5 point Likert scale, very easy = 5, very difficult = 1
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:
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
Surgeon rated ease of intra-operative localisation
5 point Likert scalevery easy = 5, very difficult = 1
Magtrace® Tracer counts for excised lymph nodes during SLNB procedures
Magtrace® Tracer counts for excised lymph nodes during SLNB procedures
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.
Success rate of maintained marker position at the time of removal as determined by specimen X-ray and or Sentimag Gen3 system.
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