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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03203668
Other study ID # 77/11/12
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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