UnknownPhase EARLY_1

Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Oncology

Eligibility highlights

Primary endpoint

•Standardized uptake value

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04185350

Org study IDNJCNMC-GLP-1

Timeline

Milestones

Study start2019-05-05actual

Study first posted2019-12-04actual

Last update posted2019-12-04actual

Primary completion2020-04-05estimated

Study completion2020-05-05estimated

Assets

Investigational agents

Exenatide

Who this study enrolls

Oncology

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. The patient volunteers and signs an informed consent form.

2. age ≥18 and ≤75 years old;

3. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad;

4. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration <3.0 mM, insulin >3 µU/ml, and C-peptide >0.6 ng/ml);

5. Conventional imaging within 3 month.

Exclusion criteria

1. Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;

2. Breast feeding;

3. Pregnancy or the wish to become pregnant within 6 months;

4. Renal function: serum creatinine > 3.0 mg/dl;

5. Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence of Adverse Events

Time frame:Adverse events within 1 week after the injection and scanning of patients will be followed and assessed

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Standardized uptake value

Time frame:1 year

descriptive

Secondary/protocol endpoint/low confidence

GLP-1 receptor expression by histology compared to tracer uptake

Time frame:1 year

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.