← Trials/Trial dossier/NCT03189953

GLP-1-AHH

CompletedPhase 1, PHASE2

68Ga-NODAGA-exendin-4 PET/CT for Diagnostic Imaging in AHH

68Ga-NODAGA-exendin-4 PET/CT in Patients With AHH - a Prospective Comparative Evaluation of Preoperative Imaging

Lead sponsor

Radboud University Medical Center

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Oncology

Key I/E criterion

—

Primary endpoint

•Tumor visualization by 68Ga-NODAGA-exendin-4 PET/CT and standard imaging

Identifiers

Registered as

NCT IDNCT03189953

Org study IDNL50643.091.14

Secondary ID2014-003167-38

Secondary ID602812European Commission

Timeline

Milestones

Study first posted2017-06-16actual

Last update posted2021-06-16actual

Study start2015-04 (month precision)

Primary completion2021-01actual (month precision)

Study completion2021-05actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Oncology

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Biochemically proven endogenous hyperinsulinemic hypoglycemia

•Signed informed consent

•Standard imaging not older than 8 weeks.

Exclusion criteria

•Breast feeding

•Pregnancy or the wish to become pregnant within 6 months

•Calculated creatinine clearance below 40ml/min

•Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions)

•Age < 18 years

•No signed informed consent

Endpoints (5)

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

Calculation of the organ- and effective dose of 68Ga-NODAGA-exendin 4

Time frame:1 year

descriptive

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Tumor visualization by 68Ga-NODAGA-exendin-4 PET/CT and standard imaging

Time frame:1 year

descriptive

Secondary/protocol endpoint/low confidence

Retrospective surgery planning, type of surgery based on image analysis

Time frame:1 year

descriptive

Secondary/protocol endpoint

Calculation and comparison of the interobserver variability of 68Ga-NODAGA-exendin 4 PET/CT and EUS combined with triple phase CT or MRI

Time frame:up to 24 months

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 1, 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 1, 2026 snapshot.