Breast cancer.
Conditions
Interventions
Patients with stage I-II biopsy proven breast cancer who undergo a standard lumpectomy combined with a sentinel lymph node (SLN) procedure, will receive an peritumoural injection with indocyanine gree
Sponsors
University Medical Center Groningen (UMCG), Department of Surgery.
Eligibility
Inclusion criteria
Inclusion criteria: Women above the age of 21 with biopsy-proven breast cancer, and who are planning to undergo sentinel lymph node mapping for staging and treatment of their disease.
Exclusion criteria
Exclusion criteria: 1. Refusal of the patient to be included in the study; 2. Pregnant or breast-feeding; 3. Significant renal dysfunction (serum creatinine above 400 micromol/L); 4. Significant cardiac and/or pulmonary disease (ASA III-IV); 5. History of iodine allergy or anaphylactic reactions to insect bites or medication; 6. Presence or history of hyperthyroidism; 7. Recent surgery on the armpit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoints of this feasibility study are ergonomics and function of the imaging system. The NIRF imaging system should not interfere with the standard SLN mapping procedure and used safely by the surgeon while detection of ICG takes place. Safely is defined as: no increased risk of infection, no interference with the standard procedure and no excessive prolongation of the operative procedure (i.e. more than 2,5 hours). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint of this feasibility study is the number and location of detected sentinel lymph nodes compared to the standard detection of SLNs with the use of patent blue and technetium-99 labeled colloid. | — |
Contacts
Public ContactG.M. Dam, van
University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen
Outcome results
None listed