18F-fluorocholine PET/CT Imaging in Hyperparathyroidism

Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03203668
• Other study ID #: 77/11/12
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2017
• Last updated: June 30, 2017
• Start date: January 1, 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2017
• Source: University Medical Centre Ljubljana
• Contact: Luka Lezaic, MD PhD
• Phone: +386 1 522 84 50
• Email: luka.lezaic[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism

Intervention

Radiation:
• 18F-choline PET/CT
18F-choline PET/CT imaging (neck, mediastinum)

Locations

Country	Name	City	State
Slovenia	Department for nuclear medicine, University medical centre Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (3)

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 (18)F-Fluorocholine PET/CT. Eur J Surg Oncol. 2017 Jan;43(1) — View Citation

Lezaic L, Rep S, Sever MJ, Kocjan T, Hocevar M, Fettich J. ¹8F-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/s00 — View 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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity & Specificity	Ability to detect the hyperfunctioning parathyroid tissue	3 months
Secondary	Biochemical/clinical outcome - iPTH levels	Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels [pg/mL])	1 year
Secondary	Biochemical/clinical outcome - Ca2+ levels	Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels [mmol/L])	1 year
Secondary	Improvement in patient management - operating time	Duration of surgical procedure (minutes)	3 years
Secondary	Improvement in patient management - duration of hospital stay	Duration of hospital stay (hours)	3 years
Secondary	Improvement in patient management - complications of surgery	Complications (number)	3 years
Secondary	Improvement in patient management - cost	Expenses of surgical/hospital management (EUR)	3 years