Hyperparathyroidism, PrimaryPhase 3NCT04895631
18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
A Phase 3 study testing 18F-Fluorocholine and Positron emission tomography (PET) in people with Hyperparathyroidism, Primary, run by Thomas Hope at 1 site in United States.
Trial summary
This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Hyperparathyroidism, Primary
- What is being tested?
- 18F-Fluorocholine and Positron emission tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >= 13 years.
- Biochemically proven hyperparathyroidism and an indication for surgery.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Current Pregnancy.
- Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94107
About this study
This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.
Read the detailed description
PRIMARY OBJECTIVE:
- To investigate the performance (accuracy) of 18F-fluorocholine PET in the detection of hyperfunctioning parathyroid glands in surgical patients with biochemically proven primary hyperparathyroidism.
OUTLINE:
Participants will receive a single dose of 18F-Fluorocholine at the time the participant undergoes a single imaging study using 18F-fluorocholine. Study related procedures will end after the study visit. Participants who undergo subsequent parathyroidectomy, will have the results reviewed and compared to the results from the imaging study
- Conditions
- Hyperparathyroidism, Primary
- Being tested
- 18F-Fluorocholine, Positron emission tomography (PET)
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FluorocholineDrug
Also called Fluorocholine
One-time injection of 4-7 millicurie (mCi)
Positron emission tomography (PET)Procedure or surgery
Also called PET
Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
| Study group | Role | What they receive |
|---|---|---|
| Fluorocholine PET Imaging | Experimental | Patients will undergo a single fluorocholine PET imaging study prior to surgery. Receives: Drug: 18F-Fluorocholine; Procedure: Positron emission tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging
Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology as compared to sestamibi imaging. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.
Measured: Up to 1 year
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using predefined threshold
Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology compared to a predefined threshold. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.
Measured: Up to 1 year
Secondary outcomes (1)
Detection rate of 18F-fluorocholine PET
The detection rate of 18F-fluorocholine PET in participants who have not undergone surgical resection will be reported
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start30 Jun 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperparathyroidism, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Hope
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Thomas Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895631
- Sponsor's protocol ID
- 20-32553
- Status last verified
- Apr 2026
- First submitted
- 13 May 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
- ClinicalTrials.gov ID
- NCT04895631
- Acronym / sponsor ID
- 20-32553
- Conditions
- Hyperparathyroidism, Primary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Thomas HopeUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.
Detailed description
PRIMARY OBJECTIVE:
- To investigate the performance (accuracy) of 18F-fluorocholine PET in the detection of hyperfunctioning parathyroid glands in surgical patients with biochemically proven primary hyperparathyroidism.
OUTLINE:
Participants will receive a single dose of 18F-Fluorocholine at the time the participant undergoes a single imaging study using 18F-fluorocholine. Study related procedures will end after the study visit. Participants who undergo subsequent parathyroidectomy, will have the results reviewed and compared to the results from the imaging study
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorocholine PET Imaging | Experimental | Drug: 18F-Fluorocholine, Procedure: Positron emission tomography (PET)Patients will undergo a single fluorocholine PET imaging study prior to surgery. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 13 years.
- Biochemically proven hyperparathyroidism and an indication for surgery.
- Ability to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (2 listed)
- Current Pregnancy.
- Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FluorocholineAlso: FluorocholineOne-time injection of 4-7 millicurie (mCi) | Drug | Fluorocholine PET Imaging |
| Positron emission tomography (PET)Also: PETImaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities | Procedure or surgery | Fluorocholine PET Imaging |
Primary outcome
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging
Time frame: Up to 1 year
Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology as compared to sestamibi imaging. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using predefined threshold
Time frame: Up to 1 year
Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology compared to a predefined threshold. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.
1 secondary outcome
Detection rate of 18F-fluorocholine PET
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Hope, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F-Fluorocholine and Positron emission tomography (PET) in people with Hyperparathyroidism, Primary, run by Thomas Hope at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.