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Clinical Trials/EUCTR2014-003167-38-FI
EUCTR2014-003167-38-FI
Active, not recruiting
Phase 1

Evaluation of preoperative diagnostic imaging for adult endogenous hyperinsulinemic hypoglycaemia by PET imaging with 68Ga-NODAGA-exendin-4 compared to standard care imaging procedures - GLP-1-AHH

Hospital District of Southwest Finland, Turku University Hospital0 sites56 target enrollmentMay 23, 2017
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ConditionsAdult endogenous hyperinsulinemic hypoglycaemiaMedDRA version: 20.0Level: LLTClassification code 10077227Term: Hyperinsulinemic hypoglycemiaSystem Organ Class: 100000004861Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Adult endogenous hyperinsulinemic hypoglycaemia
Sponsor
Hospital District of Southwest Finland, Turku University Hospital
Enrollment
56
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 23, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hospital District of Southwest Finland, Turku University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic symptoms in the fasting state with low plasma glucose, inappropriately high serum insulin and C\-peptide concentrations
  • •? Signed informed consent
  • •? Standard imaging not older than 8 weeks. This includes a triple\-phase CT or MRI, somatostatin receptor imaging (68Ga\-DOTATOC PET) and endocopic ultrasound (EUS). Protocols that should be followed for these procedures can be found in the annex.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 9
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 1

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

Outcomes

Primary Outcomes

Not specified

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