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Delfa

← All trials/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

Asset

Exenatide

GLP-1 agonist

Listed sites

0

Recruiting sites

-

Estimated enrollment

56

Study population

Oncology

Eligibility highlights

-

Primary endpoint

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

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 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

Who this study enrolls

Oncology

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)
4
Safety / tolerability / PK
1

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 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.