18F-fluorocholine PET/CT Imaging in Hyperparathyroidism
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|ClinicalTrials.gov Identifier: NCT03203668|
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hyperparathyroidism||Radiation: 18F-choline PET/CT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Value of 18F-fluorocholine PET/CT Imaging in Localization of Hyperfunctioning Parathyroid Tissue in Hyperparathyroidism|
|Actual Study Start Date :||January 1, 2013|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Choline PET/CT imaging added to conventional imaging assessment in hyperparathyroidism (parathyroid scintigraphy, ultrasound, CT or MRI if indicated)
Radiation: 18F-choline PET/CT
18F-choline PET/CT imaging (neck, mediastinum)
- Sensitivity & Specificity [ Time Frame: 3 months ]Ability to detect the hyperfunctioning parathyroid tissue
- Biochemical/clinical outcome - iPTH levels [ Time Frame: 1 year ]Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels [pg/mL])
- Biochemical/clinical outcome - Ca2+ levels [ Time Frame: 1 year ]Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels [mmol/L])
- Improvement in patient management - operating time [ Time Frame: 3 years ]Duration of surgical procedure (minutes)
- Improvement in patient management - duration of hospital stay [ Time Frame: 3 years ]Duration of hospital stay (hours)
- Improvement in patient management - complications of surgery [ Time Frame: 3 years ]Complications (number)
- Improvement in patient management - cost [ Time Frame: 3 years ]Expenses of surgical/hospital management (EUR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203668
|Contact: Luka Lezaic, MD PhD||+386 1 522 84 email@example.com|
|Department for nuclear medicine, University medical centre Ljubljana||Recruiting|
|Ljubljana, Slovenia, 1000|
|Contact: Luka Lezaic, Md PhD +386 1 522 84 50 firstname.lastname@example.org|