18F-fluorocholine PET/CT Imaging in Hyperparathyroidism

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Unknown status

CT.gov ID

NCT03203668

Collaborator

Institute of Oncology Ljubljana (Other)

1,000

Enrollment

Location

Arm

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism	Radiation: 18F-choline PET/CT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Choline PET/CT 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)

Arm

Intervention/Treatment

Other: Choline PET/CT

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)

Outcome Measures

Primary Outcome Measures

Sensitivity & Specificity [3 months]
Ability to detect the hyperfunctioning parathyroid tissue

Secondary Outcome Measures

Biochemical/clinical outcome - iPTH levels [1 year]
Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels [pg/mL])
Biochemical/clinical outcome - Ca2+ levels [1 year]
Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels [mmol/L])
Improvement in patient management - operating time [3 years]
Duration of surgical procedure (minutes)
Improvement in patient management - duration of hospital stay [3 years]
Duration of hospital stay (hours)
Improvement in patient management - complications of surgery [3 years]
Complications (number)
Improvement in patient management - cost [3 years]
Expenses of surgical/hospital management (EUR)