18F-fluorocholine PET/CT Imaging in Hyperparathyroidism
Primary Purpose
Hyperparathyroidism
Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
18F-choline PET/CT
Sponsored by

About this trial
This is an interventional diagnostic trial for Hyperparathyroidism focused on measuring Hyperparathyroidism, Imaging, Scintigraphy, 18F-choline, 18F-fluorocholine, PET, PET/CT
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
Sites / Locations
- Department for nuclear medicine, University medical centre LjubljanaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Choline PET/CT
Arm Description
Choline PET/CT imaging added to conventional imaging assessment in hyperparathyroidism (parathyroid scintigraphy, ultrasound, CT or MRI if indicated)
Outcomes
Primary Outcome Measures
Sensitivity & Specificity
Ability to detect the hyperfunctioning parathyroid tissue
Secondary Outcome Measures
Biochemical/clinical outcome - iPTH levels
Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels [pg/mL])
Biochemical/clinical outcome - Ca2+ levels
Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels [mmol/L])
Improvement in patient management - operating time
Duration of surgical procedure (minutes)
Improvement in patient management - duration of hospital stay
Duration of hospital stay (hours)
Improvement in patient management - complications of surgery
Complications (number)
Improvement in patient management - cost
Expenses of surgical/hospital management (EUR)
Full Information
NCT ID
NCT03203668
First Posted
April 17, 2017
Last Updated
June 30, 2017
Sponsor
University Medical Centre Ljubljana
Collaborators
Institute of Oncology Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT03203668
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
Institute of Oncology Ljubljana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism
Keywords
Hyperparathyroidism, Imaging, Scintigraphy, 18F-choline, 18F-fluorocholine, PET, PET/CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Choline PET/CT
Arm Type
Other
Arm Description
Choline PET/CT imaging added to conventional imaging assessment in hyperparathyroidism (parathyroid scintigraphy, ultrasound, CT or MRI if indicated)
Intervention Type
Radiation
Intervention Name(s)
18F-choline PET/CT
Intervention Description
18F-choline PET/CT imaging (neck, mediastinum)
Primary Outcome Measure Information:
Title
Sensitivity & Specificity
Description
Ability to detect the hyperfunctioning parathyroid tissue
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Biochemical/clinical outcome - iPTH levels
Description
Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels [pg/mL])
Time Frame
1 year
Title
Biochemical/clinical outcome - Ca2+ levels
Description
Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels [mmol/L])
Time Frame
1 year
Title
Improvement in patient management - operating time
Description
Duration of surgical procedure (minutes)
Time Frame
3 years
Title
Improvement in patient management - duration of hospital stay
Description
Duration of hospital stay (hours)
Time Frame
3 years
Title
Improvement in patient management - complications of surgery
Description
Complications (number)
Time Frame
3 years
Title
Improvement in patient management - cost
Description
Expenses of surgical/hospital management (EUR)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luka Lezaic, MD PhD
Phone
+386 1 522 84 50
Email
luka.lezaic@kclj.si
Facility Information:
Facility Name
Department for nuclear medicine, University medical centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luka Lezaic, Md PhD
Phone
+386 1 522 84 50
Email
luka.lezaic@kclj.si
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25063039
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.
Results Reference
result
PubMed Identifier
26834518
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.
Results Reference
result
PubMed Identifier
27776943
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.
Results Reference
result
Learn more about this trial
18F-fluorocholine PET/CT Imaging in Hyperparathyroidism
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