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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)

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) - Detecting beta cells with a fluorescent tracer (BETA-light)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46762
Enrollment
11
Registered
2018-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulinoma

Interventions

A total of 9 patients will receive an injection of Exendin-800CW 24 hours before surgery. Directly after surgery the pancreatic tissue will be examined on the back-table and by image-guided patholog

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
- Back-table imaging of the surgical specimen directly after excision to identify fluorescence signals of Exendin-800CW - Correlation of fluorescence signals with histology. - Calculating target to background ratios in fluorescence imaging obtained directly after the surgical procedure and fluorescence images obtained during ex vivo analyses in bread loaf slices and in histological slices (odyssey scanner, fluorescence microscopy). - Adverse events (AE), serious adverse events (SAE), and suspected unsuspected serious adverse reactions (SUSARs).

Secondary

MeasureTime frame
-

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)