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18F-fluorocholine PET/CT Imaging in Hyperparathyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03203668
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : July 2, 2017
Institute of Oncology Ljubljana
Information provided by (Responsible Party):
Luka Lezaic MD PhD, University Medical Centre Ljubljana

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
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 : January 1, 2013
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Sensitivity & Specificity [ Time Frame: 3 months ]
    Ability to detect the hyperfunctioning parathyroid tissue

Secondary Outcome Measures :
  1. Biochemical/clinical outcome - iPTH levels [ Time Frame: 1 year ]
    Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels [pg/mL])

  2. Biochemical/clinical outcome - Ca2+ levels [ Time Frame: 1 year ]
    Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels [mmol/L])

  3. Improvement in patient management - operating time [ Time Frame: 3 years ]
    Duration of surgical procedure (minutes)

  4. Improvement in patient management - duration of hospital stay [ Time Frame: 3 years ]
    Duration of hospital stay (hours)

  5. Improvement in patient management - complications of surgery [ Time Frame: 3 years ]
    Complications (number)

  6. Improvement in patient management - cost [ Time Frame: 3 years ]
    Expenses of surgical/hospital management (EUR)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03203668

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Contact: Luka Lezaic, MD PhD +386 1 522 84 50

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Department for nuclear medicine, University medical centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Luka Lezaic, Md PhD    +386 1 522 84 50   
Sponsors and Collaborators
University Medical Centre Ljubljana
Institute of Oncology Ljubljana

Publications of Results:
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Responsible Party: Luka Lezaic MD PhD, MD PhD, University Medical Centre Ljubljana Identifier: NCT03203668     History of Changes
Other Study ID Numbers: 77/11/12
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luka Lezaic MD PhD, University Medical Centre Ljubljana:

Additional relevant MeSH terms:
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Parathyroid Diseases
Endocrine System Diseases
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents