pre-operative imaging to detect tumours in patients with AHH using the radiactive labeled exendin-4
- Conditions
- Adult endogenous hyperinsulinemic hypoglycemiaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003167-38-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 56
•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, 68Ga-DOTATATE or 111In-DTPA-octreotide SPECT/CT) 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 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method