breast cancer, sentinel lymph node, intraoperative imaging, image-guided surgery
Conditions
Interventions
Patients with palpable operable invasive breast cancer stage I-II undergoing a lumpectomy, combined with a sentinel lymph node procedure, will receive prior to a lumpectomy and SLN procedure an intrat
Sponsors
Department of Surgery, University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with operable invasive breast cancer stage (T1-2N0-1 – stage I and II) proven by histology on a biopsy.
Exclusion criteria
Exclusion criteria: 1. Pregnant women. 2. Significant renal (creatinine >, cardiac, or pulmonary disease (ASA III-IV). 3. History of iodine allergy or anaphylactic reactions to insect bites or medication. 4. Presence or history of hyperthyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Ergonomics and function of the NIRF imaging system - the NIRF imaging system must not interfere with the standard Sentinel Lymph Node mapping procedure and should be used safely by the surgeon. Duration of data aquisition: 1,5 hour clinical procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Identify sentinel lymph nodes within the allocated procedure (usually 1-1,5 hour) | — |
Contacts
Public ContactG.M. Dam, van
University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen
Outcome results
None listed