Detection of pituitary neuroendocrine tumor (PitNET) tissue during endoscopic transsphenoidal surgery using Bevacizumab-800CW: a single center feasibility and dose finding study

Completed

Conditions: pituitary adenoma
Pituitary neuroendocrine tumor (PitNET)
10021112
10014710

Registration Number: NL-OMON49831

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Age >= 18 years
- 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
medications
- Within 6 months prior to inclusion: myocardial infarction, TIA, CVA,
pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina
pectoris

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The measured fluorescence intensity that is able to distinguish tumorous from<br /><br>non-tumorous tissue.<br /><br>- Safety evaluation of vital parameters, adverse events (AE), serious adverse<br /><br>events (SAE) and suspected unexpected serious adverse reactions (SUSAR).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Macroscopic fluorescent signal levels and tracer distribution observed by in<br /><br>vivo NIR fluorescence imaging using the fluorescence endoscopic system.<br /><br>- Macroscopic fluorescent signal levels and tracer distribution observed by ex<br /><br>vivo NIR fluorescence imaging of the freshly excised specimen directly after<br /><br>excision.<br /><br>- Intraoperative MDSFR/SFF spectroscopy measurements.<br /><br>- Fluorescent signal levels on fluorescence images obtained during ex vivo<br /><br>analyses in histological slices<br /><br>- Standard histopathological examination (H&E staining) to correlate<br /><br>fluorescent signal with histology.<br /><br>- Histopathological examinations related to ex vivo VEGF expression and<br /><br>bevacizumab-800CW distribution.</p><br>