Breast cancer.
Conditions
Interventions
Four (4) hours prior to the surgical procedure, the patient receives an injection with 0,3 mg/kg bodyweight folate-FITC compound in the cephalic vein through an intravenous infusion. The standard lump
Sponsors
University Medical Center Groningen (UMCG), Department of Surgery.
Eligibility
Inclusion criteria
Inclusion criteria: Women above the age of 21 who have biopsy-proven stage I-II breast cancer and who are planning to undergo lumpectomy as a treatment for their disease. Furthermore, folate receptor (FR) expression of the tumour must be strong (¡Ý2+), as determined by immunohistochemistry prior to surgery.
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 creatinin above 400 micromol/L); 4. Cardiac and/or pulmonary disease (ASA III-IV); 5. History of fluorescein allergy or anaphylactic reactions to insect bites or medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of this feasibility study is the intra-operative detection rate of breast carcinoma by a folate-FITC enhanced optical imaging device. | — |
Contacts
Public ContactG.M. Dam, van
University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen
Outcome results
None listed