Comparison of two nuclear imaging procedures - Tc-99m MIBI scintigraphy and F-18 Choline PET/CT - in patients with elevated parathyroid hormone and calcium blood levels due to a benign enlargement of a parathyroid gland

Conditions: Primary hyperparathyroidism due to parathyroid adenoma
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2015-000411-40-AT

Lead Sponsor: Department of Nuclear Medicine and Endocrinology, Paracelsus Medical University Salzburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 52

Inclusion Criteria

Patients with primary hyperparathyreoidism (elevated blood levels of parathyroid hormone and calcium)
Patients aged 18 - 85 years
Written informed consent of the patient
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 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

Age below 18 years (Minors)
limited contractual capability
Pregnancy or lactation
Patients with a secondary or tertiary hyperparathyreoidism
Patients with conservative management (no operative excision of the parathyroid gland planned)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In clinical routine, imaging with Tc-99m MIBI scintigraphy is used to diagnose parathyroid adenomas in patients with primary hyperparathyreoidism.<br>However, F-18 Choline PET/CT seems to be more sensitive in the diagnosis of parathyroid adenomas.<br><br>Main objective of the trial is the comparison of Tc-99m MIBI scintigraphy and F-18 Choline PET/CT in the diagnosis and localization of parathyroid adenomas, with the primary hypothesis, that F-18 Cholin PET/CT has a higher sensitivity for localization of parathyroid adenomas than Tc-99m MIBI scintigraphy.;Secondary Objective: Specificity of the detection of parathyroid adenomas comparing F-18 Choline PET/CT and Tc-99m MIBI scintigraphy;Primary end point(s): Inclusion of 52 patients (who underwent both F-18 Choline PET/CT and Tc-99m MIBI scintigraphy and histopathological confirmation of parathyroid adenoma after surgery)<br><br>;Timepoint(s) of evaluation of this end point: evaluation after parathyroid surgery

Secondary Outcome Measures