18F-fluorocholine PET/CT Imaging in Hyperparathyroidism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic Value of 18F-fluorocholine PET/CT Imaging in Localization of Hyperfunctioning Parathyroid Tissue in Hyperparathyroidism

Conditions
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Hyperparathyroidism

Intervention / Treatment
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* Radiation: 18F-choline PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Biochemically proven hyperparathyroidism (elevated iPTH, elevated on normal Ca2+) or elevated Ca2+ and inadequately supressed iPTH Exclusion Criteria: Age under 18 years Pregnancy Clinical history of oncological, inflammatory/infectious disease of the head and neck

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Choline PET/CT<br>Choline PET/CT imaging added to conventional imaging assessment in hyperparathyroidism (parathyroid scintigraphy, ultrasound, CT or MRI if indicated) | Radiation: 18F-choline PET/CT<br>* 18F-choline PET/CT imaging (neck, mediastinum)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity & Specificity | Ability to detect the hyperfunctioning parathyroid tissue | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical/clinical outcome - iPTH levels | Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels [pg/mL]) | 1 year | 
| Biochemical/clinical outcome - Ca2+ levels | Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels [mmol/L]) | 1 year | 
| Improvement in patient management - operating time | Duration of surgical procedure (minutes) | 3 years | 
| Improvement in patient management - duration of hospital stay | Duration of hospital stay (hours) | 3 years | 
| Improvement in patient management - complications of surgery | Complications (number) | 3 years | 
| Improvement in patient management - cost | Expenses of surgical/hospital management (EUR) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperparathyroidism, Imaging, Scintigraphy, 18F-choline, 18F-fluorocholine, PET, PET/CT