DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02127541

CompletedPhase NA

New Imaging Procedure for the Localisation of Insulinoma

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

52

actual

Study population

Oncology

Key I/E criterion

—

Primary endpoints

•Measuring Tumour to Background Ratio•Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02127541
Org study IDEKBB 163/12

Timeline

Milestones

Study start2014-01-06
Study first posted2014-04-30estimated
Last update posted2018-04-18actual
Primary completion2017-11actual (month precision)
Study completion2017-11actual (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 hyperinsulinaemic hypoglycaemia in the fasting state with neuroglycopenic symptoms or autologous Islet Cell transplantation in the forearm
•Conventional imaging (CT,MRI or EUS) not older than 2 months
•Signed written consent
•Age above 18 years

Exclusion criteria

•Kidney failure (creatinine > 140micromol/l)
•Known allergies against Exendin-4 (Byetta or Bydureon)
•Pregnancy
•Breastfeeding
•Medication with Byetta or Bydureon
•Evidence for malignancy (extrapancreatic tumor manifestations)

Endpoints (7)

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)
5
Safety / tolerability / PK
1
Other clinical outcomes
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint/low confidence

Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4

Time frame:4 years

descriptive

componentsFasting glucose, change, Nausea, Vomiting

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Sensitivity of tumour localisation with 68-DOTA-Exendin-4 PET/CT, 111 In-DOTA-exendin-4 SPECT/CT and standardized MRI in comparison with conventional imaging (CT,MRI and EUS)

Time frame:4 years

descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Measuring Tumour to Background Ratio

Time frame:4 years

descriptive

Primary/protocol endpoint/low confidence

Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.

Time frame:4 years

descriptive

Secondary/protocol endpoint/low confidence

Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT

Time frame:4 years

descriptive

Secondary/protocol endpoint/low confidence

Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT

Time frame:4 years

descriptive

Secondary/protocol endpoint/low confidence

Comparison of the angiogenesis markers with the those of breast carcinoma patients

Time frame:4 years

descriptive

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.