18F-fluorocholine PET/CT Imaging in Hyperparathyroidism

June 30, 2017 updated by: Luka Lezaic MD PhD, University Medical Centre Ljubljana

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Department for nuclear medicine, University medical centre Ljubljana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity & Specificity
Time Frame: 3 months
Ability to detect the hyperfunctioning parathyroid tissue
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemical/clinical outcome - iPTH levels
Time Frame: 1 year
Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (iPTH levels [pg/mL])
1 year
Biochemical/clinical outcome - Ca2+ levels
Time Frame: 1 year
Normalization of biochemical abnormalities related to hyperfunctioning parathyroid tissue (Ca2+ levels [mmol/L])
1 year
Improvement in patient management - operating time
Time Frame: 3 years
Duration of surgical procedure (minutes)
3 years
Improvement in patient management - duration of hospital stay
Time Frame: 3 years
Duration of hospital stay (hours)
3 years
Improvement in patient management - complications of surgery
Time Frame: 3 years
Complications (number)
3 years
Improvement in patient management - cost
Time Frame: 3 years
Expenses of surgical/hospital management (EUR)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Centre Ljubljana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute of Oncology Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 77/11/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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