Evaluation of novel PET tracer in PET imaging in patients with hypoglycaemia due to excess insulin secretio

Phase 1

• Conditions: Adult endogenous hyperinsulinemic hypoglycaemia; MedDRA version: 20.0Level: LLTClassification code 10077227Term: Hyperinsulinemic hypoglycemiaSystem Organ Class: 100000004861; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2014-003167-38-FI
• Lead Sponsor: Hospital District of Southwest Finland, Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-23
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 56

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
?

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified