Detection of PitNET Tissue During TSS Using Bevacizumab-800CW
Detection of PitNET Tissue During TSS Using Bevacizumab-800CW
There is a need for improved visualization of presence and extent of pituitary neuroendocrine
 tumor (PitNET) tissue during transsphenoidal surgery (TSS), especially in tumors invading the
 cavernous sinus (CS). Optical molecular imaging of PitNET associated biomarkers is a
 promising technique to accommodate this need. Vascular Endothelial Growth Factor (VEGF-A) is
 overexpressed in PitNET tissue compared to normal pituitary tissue and has proven to be a
 valid target for molecular imaging. Bevacizumab is an antibody that binds VEGF-A. By
 conjugating a fluorescent dye to this antibody, the fluorescent tracer molecule
 bevacizumab-800CW is created, which binds to VEGF-A. The investigators hypothesize that
 bevacizumab-800CW accumulates in PitNET tissue, enabling visualization using a molecular
 fluorescence endoscopy system. In this pilot intervention study the investigators will
 determine the feasibility of using microdoses (4.5, 10 and 25 mg) of bevacizumab-800CW to
 detect PitNET tissue intraoperatively.
Inclusion Criteria:

 -  Patients with an established diagnosis of PitNET with a Knosp grade of 3 or 4 who are
 scheduled to undergo TSS.

 -  WHO performance status 0-2

 -  Signed written informed consent

 Exclusion Criteria:

 -  Medical or psychiatric conditions that compromise the patient's ability to give
 informed consent

 -  Pregnant or lactating women. Documentation of a negative pregnancy test must be
 available for woman of childbearing potential. Woman of childbearing potential are
 pre- menopausal women with intact reproductive organs and women less than two years
 after menopause

 -  History of infusion reactions to bevacizumab or other monoclonal antibody therapies.

 -  Inadequately controlled hypertension with or without current antihypertensive
 medication

 -  Within 6 months prior to inclusion: myocardial infarction, TIA, CVA, pulmonary
 embolism, uncontrolled chronic hepatic failure, unstable angina pectoris