18F-fluorocholine PET/CT Imaging in Hyperparathyroidism
- Conditions
- Hyperparathyroidism
- Interventions
- Radiation: 18F-choline PET/CT
- Registration Number
- NCT03203668
- Lead Sponsor
- University Medical Centre Ljubljana
- Brief Summary
To assess the efficiency of 18F-fluorocholine PET/CT in localization of hyperfunctioning parathyroid tissue in hyperparathyroidism, thereby enabling minimally invasive surgical approaches with fewer complications and comparable success rates
- Detailed Description
Primary hyperparathyroidism is a common endocrine disorder for which the diagnosis is biochemical and therapy surgical in the vast majority of cases; in secondary and tertiary hyperparathyroidism, surgical treatment is usually chosen when conservative measures fail to control the condition. The previously used surgical approach of bilateral neck exploration is being replaced by minimally invasive procedures, whose advantage is shorter duration of operation and general anesthesia, lower morbidity and fewer complications with comparable success rates.
A prerequisite for minimally invasive surgery is successful localization of the offending parathyroid tissue. Most commonly used imaging modality for this purpose is parathyroid scintigraphy with 99mTc-sestaMIBI, usually supplemented by ultrasound of the neck. Overall, parathyroid scintigraphy is a sensitive method for localization of hyperfunctioning parathyroid tissue; however, its diagnostic performance is significantly lower in patients with multiple parathyroid lesions.
In comparison to conventional nuclear medicine imaging approaches for localization of the offending parathyroid tissue, positron emission tomography with computed tomography (PET/CT) offers superior image resolution with an additional advantage of attenuation correction and co-registration of functional and anatomical information. 18F-fluorocholine is a PET tracer which is commonly used for prostate cancer imaging. In contrast to 18F-fluorodeoxyglucose (18F-FDG), it is also taken up by well-differentiated neoplasms in which 18F-FDG uptake is unreliable. The investigators hypothesize that 18F-fluorocholine might be efficiently taken up by parathyroid adenomata and/or hyperplasia.
The aim of this study is to investigate the efficiency of localization of hyperfunctioning parathyroid tissue with 18F-fluorocholine PET/CT in patients with primary hyperparathyroidism and to compare its efficiency to conventional scintigraphic imaging methods for this purpose.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Age over 18 years
- Biochemically proven hyperparathyroidism (elevated iPTH, elevated on normal Ca2+) or elevated Ca2+ and inadequately supressed iPTH
- Age under 18 years
- Pregnancy
- Clinical history of oncological, inflammatory/infectious disease of the head and neck
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Choline PET/CT 18F-choline PET/CT Choline PET/CT imaging added to conventional imaging assessment in hyperparathyroidism (parathyroid scintigraphy, ultrasound, CT or MRI if indicated)
- Primary Outcome Measures
Name Time Method Sensitivity & Specificity 3 months Ability to detect the hyperfunctioning parathyroid tissue
- Secondary Outcome Measures
Name Time Method Biochemical/clinical outcome - Ca2+ levels 1 year Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels \[mmol/L\])
Biochemical/clinical outcome - iPTH levels 1 year Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels \[pg/mL\])
Improvement in patient management - cost 3 years Expenses of surgical/hospital management (EUR)
Improvement in patient management - operating time 3 years Duration of surgical procedure (minutes)
Improvement in patient management - complications of surgery 3 years Complications (number)
Improvement in patient management - duration of hospital stay 3 years Duration of hospital stay (hours)
Trial Locations
- Locations (1)
Department for nuclear medicine, University medical centre Ljubljana
🇸🇮Ljubljana, Slovenia