NCT07340437

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 6, 2026

Last Update Submit

January 14, 2026

Conditions

Insulinoma

Outcome Measures

Primary Outcomes (1)

  • Correlation between clinical indicators and PET/CT results

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

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosed or highly suspected insulinoma.

You may qualify if:

  • 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.

You may not qualify if:

  • unknown etiology of hypoglycemia at last follow-up
  • patients clinically diagnosed with insulinoma but without subsequent surgical intervention or biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chengdu, China

Location

MeSH Terms

Conditions

Insulinoma

Condition Hierarchy (Ancestors)

Adenoma, Islet CellAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

February 1, 2023

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

CN(1)