A new kind of scan for patients with an overactive parathyroid
- Conditions
- on familial primary hyperparathyroidismTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2014-004590-16-NL
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-Patients who have signed informed consent
-Age = 18 years
-Biochemically proven PHP
-Indication for surgery
-Negative SPECT/CT
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
Exclusion Criteria
-Pregnancy
-Patients with MEN syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigating the added value of 18F-Fluormethylcholine PET/CT for localising the pathological parathyroid in patients with biochemically proven primary hyperparathyroidism;Secondary Objective: To investigate possible factors that influence the outcome of the scan ;Primary end point(s): post-operative ionised calcium serum level ;Timepoint(s) of evaluation of this end point: 1 week
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Pathology report of the resected parathyroid(s);Timepoint(s) of evaluation of this end point: 1 week post-operative