Breast Cancer
Conditions
Interventions
Patients in the first training phase will receive the investigational technology (Orion Magnetic Localization) alongside the standard of care Radioactive Seed Localization. Patients in the second Orio
Sponsors
Sirius Medical Systems B.V.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient is willing and able to provide informed consent for the investigation and to comply to the schedule of assessments of the clinical investigation 2. Patient is at least 18 years of age 3. Patient is diagnosed with a single, pathologically confirmed unifocal breast tumour (DCIS or invasive) 4. The tumour is ultrasound visible 5. Patient is indicated for primary breast conserving surgery 6. Patient is indicated for preoperative localization using a single (radioactive) seed
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant 2. Patient is receiving neo-adjuvant chemotherapy 3. Patient has an ICD or other active implant such as a pacemaker less than 5cm away from the intended target location 4. Patient has a proven infection or hematoma at or within 5cm of the intended target location 5. Patient is scheduled for immediate breast reconstruction (within the same surgical procedure) 6. Patient is currently participating in, or has recently exited from, or plans to be enrolled in another clinical investigation which may affect the outcomes of the current clinical investigation, as assessed by the discretion of the investigator 7. Patient is expected to require an MRI scan of the breast area in the period between implantation and surgery 8. The expected time between placement of Orion Magnetic Seed and surgery exceeds 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Performance. Number and percentage of procedures in which ORION SEEDS is present on post-operative specimen X-ray and only the ORION detector is used during surgery [=>95%] 2) Safety. Adverse events as assessed by MedDRA.Number and percentage of patients who experienced a device-related adverse event. [No SADEs] | — |
Secondary
| Measure | Time frame |
|---|---|
| In situ time Days between implantation and surgery [all cases <30 days] Accuracy of placement - Average distance between centre of SEED and centre of lesion measured on two-way mammography in mm [descriptive] Sonographic Tumour depth - Minimum distance between skin and tumour border on ultrasound imaging (mm) [descriptive] Sonographic Tumour size - Shortest and longest axis of tumour on ultrasound (mm) [descriptive] Radiologist Satisfaction - Satisfaction as measured on a questionnaire [see Appendix A] Operative time - Minutes from first incision until excision of specimen [descriptive] Transcutaneous detection - Number and percentage of procedures in which a reliable signal is measured on the intact skin preoperatively. Also note the value. [=95% of cases] Seed Confirmation - Seed detected in excised specimen using ORION detector [descriptive] Surgeon Satisfaction - Satisfaction as measured on a questionnaire Patient Convenience - Patient convenience reported measured using a single quesiton Margin Status - Margin status defined per NABON Dutch national guidelines [descriptive] Reoperation - Second, separate surgical procedure of same lesion or area indicated after multidisciplinary discussion [descriptive] | — |
Contacts
Public ContactBram Schermers
Sirius Medical Systems B.V
Outcome results
None listed