Medical imaging using radioactive pharmaceuticals to localize abnormal parathyroid glands in patients with negative convenctional imaging, as a necessary condition for planning an optimal surgical treatment
Phase 1
- Conditions
- Primary hyperthyroidismMedDRA version: 20.0 Level: LLT Classification code 10036693 Term: Primary hyperparathyroidism System Organ Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2019-002729-31-ES
- Lead Sponsor
- Fundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Patients with primary hyperparathyroidism
Eligible for parathyroid surgery
Negative, inconclusive or discordant preoperative imaging (both parathyroid scintigraphy and cervical ultrasound), performed within 6 months before PET-CT scan with 18F-Fluorocholine
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
Patients with familial isolated primary hyperparathyroidism
Patients with multiple endocrine neoplasia (MEN)
Patients with secondary or terciary hyperparathyroidism
Patients with suspected thyroid or parathyroid cancer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the usefulness of PET-CT with 18F-Fluorocholine for preoperative localization of hyperfunctioning parathyroid glands in patients with primary hyperparathyroidism and negative conventional imaging (parathyroid scintigraphy and cervical ultrasound);<br> Secondary Objective: To investigate the correlation between SUVmax and clinical, analytical and pathological parameters.<br> To perform a cost-effectiveness analysis<br> ;Primary end point(s): Surgical resection of the hyperfunctioning parathyroid glands detected by PET-CT scan with 18F-Fluorocholine;Timepoint(s) of evaluation of this end point: Surgery must be performed within 3 months after the PET-CT scan
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Percentage of cured patients after surgery;Timepoint(s) of evaluation of this end point: 3 months after surgery