Clinical trial NCT03203668: 18F-fluorocholine PET/CT Imaging in Hyperparathyroidism
Official title: Diagnostic Value of 18F-fluorocholine PET/CT Imaging in Localization of Hyperfunctioning Parathyroid Tissue in Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperparathyroidism
Keywords: Hyperparathyroidism
Imaging
Scintigraphy
18F-choline
18F-fluorocholine
PET
PET/CT
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Institute of Oncology Ljubljana
First posted: 2017-06-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity & Specificity
timeFrame: 3 months
Secondary outcomes:
measure: Biochemical/clinical outcome - iPTH levels
timeFrame: 1 year
measure: Biochemical/clinical outcome - Ca2+ levels
timeFrame: 1 year
measure: Improvement in patient management - operating time
timeFrame: 3 years
measure: Improvement in patient management - duration of hospital stay
timeFrame: 3 years
measure: Improvement in patient management - complications of surgery
timeFrame: 3 years
measure: Improvement in patient management - cost
timeFrame: 3 years
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department for nuclear medicine, University medical centre Ljubljana
Study officials:
References:
citation: Lezaic L, Rep S, Sever MJ, Kocjan T, Hocevar M, Fettich J. (1)(8)F-Fluorocholine PET/CT for localization of hyperfunctioning parathyroid tissue in primary hyperparathyroidism: a pilot study. Eur J Nucl Med Mol Imaging. 2014 Nov;41(11):2083-9. doi: 10.1007/s00259-014-2837-0. Epub 2014 Jul 26.
citation: Rep S, Lezaic L, Kocjan T, Pfeifer M, Sever MJ, Simoncic U, Tomse P, Hocevar M. Optimal scan time for evaluation of parathyroid adenoma with [(18)F]-fluorocholine PET/CT. Radiol Oncol. 2015 Nov 27;49(4):327-33. doi: 10.1515/raon-2015-0016. eCollection 2015 Dec.
citation: Hocevar M, Lezaic L, Rep S, Zaletel K, Kocjan T, Sever MJ, Zgajnar J, Peric B. Focused parathyroidectomy without intraoperative parathormone testing is safe after pre-operative localization with 18F-Fluorocholine PET/CT. Eur J Surg Oncol. 2017 Jan;43(1):133-137. doi: 10.1016/j.ejso.2016.09.016. Epub 2016 Oct 21.