Current partner codePEPTIDESDE
NCT07340437·Not applicable·OBSERVATIONAL

Clinical Study of 18F-Exendin-4 in Insulinoma

Status

Completed

Phase

Not applicable

Enrollment

20

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The goal of this observational study is to evaluate the diagnostic value of ¹⁸F-Exendin-4 PET/CT imaging in renal insulinoma. Participants will undergo clinical evaluation and ¹⁸F-Exendin-4 PET/CT examination.

Full detailed description

Early detection, precise diagnosis, and accurate localization are key to the effective management of insulinoma, the most common functional pancreatic neuroendocrine tumor, which is predominantly benign. Histopathological examination remains the diagnostic gold standard, but invasive procedures such as biopsy carry risks of bleeding and hematoma, while rarer complications like infection or pancreatic fistula may also occur. Therefore, there is an urgent clinical need for a highly accurate, non-invasive diagnostic method. The glucagon-like peptide-1 receptor is overexpressed in insulinomas, making GLP-1R-targeted imaging a major focus in the molecular imaging of this disease. Exendin-4, an analog of GLP-1R agonists, has been shown to specifically bind to GLP-1R when labeled with ⁶⁸Ga, enabling targeted diagnosis of insulinoma. However, compared to ⁶⁸Ga, ¹⁸F offers significant advantages. Although ¹⁸F-labeled exendin-4 has been explored in preclinical studies, its clinical translation has not yet been reported. Therefore, investigating the imaging performance of ¹⁸F-exendin-4 PET/CT in insulinoma is of high clinical relevance.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Jan 14, 2026

  2. Study start

    Feb 1, 2023

  3. Primary completion

    Oct 31, 2025

  4. Study completion

    Dec 31, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 15, 2026

Outcomes

What the study measures.

Primary outcomes

Correlation between clinical indicators and PET/CT results

Time frame · 2 years

Correlation analysis of clinical biochemical indicators, endoscopic ultrasound, contrast-enhanced CT, contrast-enhanced MRI with ¹⁸F-Exendin-4 PET/CT results.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * biochemically confirmed hyperinsulinemic hypoglycemia (plasma glucose \< 3.0 mmol/L, insulin \> 3 μIU/mL, C-peptide \> 0.6 ng/mL) * surgical or biopsy-confirmed insulinoma or non-insulinoma pancreatogenous hypoglycemia syndrome, with definitive clinical diagnosis at discharge and comprehensive evaluation for hypoglycemia etiology during hospitalization. Exclusion Criteria: * unknown etiology of hypoglycemia at last follow-up * patients clinically diagnosed with insulinoma but without subsequent surgical intervention or biopsy

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Department of Endocrinology and Department of Nuclear Medicine, Sichuan Provincial People's Hospital, Chengdu, Sichuan 610072

Chengdu, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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