Detection of PitNET Tissue During TSS Using Bevacizumab-800CW (DEPARTURE)
Pituitary Tumor, Pituitary Adenoma, Pituitary Macroadenoma
About this trial
This is an interventional diagnostic trial for Pituitary Tumor
Eligibility Criteria
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
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
NIR endoscopic TSS with 4.5 mg bevacizumab-800CW
NIR endoscopic TSS with 10 mg bevacizumab-800CW
NIR endoscopic TSS with 25 mg bevacizumab-800CW
IV-administration of 4.5 mg of the fluorescent tracer bevacizumab-800CW to 3 patients with a pituitary neuroendocrine tumor (PitNET) with a Knosp grade of 3 or 4. The optimal dose will be expanded to include 6 patients.
IV-administration of 10 mg of the fluorescent tracer bevacizumab-800CW to 3 patients with a pituitary neuroendocrine tumor (PitNET) with a Knosp grade of 3 or 4. The optimal dose will be expanded to include 6 patients.
IV-administration of 25 mg of the fluorescent tracer bevacizumab-800CW to 3 patients with a pituitary neuroendocrine tumor (PitNET) with a Knosp grade of 3 or 4. The optimal dose will be expanded to include 6 patients.