Clinical pilot study to determine the feasibility of detecting pancreatic beta cells using Exendin-4-800CW targeting the glucagon-like peptide 1 receptor for future application of molecular fluorescence guided surgery in insulinoma patients (BETA-light)
Withdrawn
- Conditions
- Insulinoma10014713
- Registration Number
- NL-OMON46762
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 11
Inclusion Criteria
- Age equal to or older than 18 years;- Patients who are scheduled to undergo a pancreatectomy due to an insulinoma, another type of neuro-endocrine tumour or because of a suspected carcinoma.;- WHO performance score 0-2;- Signed informed consent
Exclusion Criteria
- Breast feeding;- Pregnancy or the wish to become pregnant within 6 months;- Calculated creatinine clearance below 40ml/min;- Evidence of other malignancy in conventional imaging (suspicious liver, bone and lung lesions);- No informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Back-table imaging of the surgical specimen directly after excision to<br /><br>identify fluorescence signals of Exendin-800CW<br /><br>- Correlation of fluorescence signals with histology.<br /><br>- Calculating target to background ratios in fluorescence imaging obtained<br /><br>directly after the surgical procedure and fluorescence images obtained during<br /><br>ex vivo analyses in bread loaf slices and in histological slices (odyssey<br /><br>scanner, fluorescence microscopy).<br /><br>- Adverse events (AE), serious adverse events (SAE), and suspected unsuspected<br /><br>serious adverse reactions (SUSARs).</p><br>
- Secondary Outcome Measures
Name Time Method <p>-</p><br>