Primary HyperparathyroidismPhase 2/3NCT07444723
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
A Phase 2/3 study testing 18F-FCH and NeuroEXPLORER in people with Primary Hyperparathyroidism and Parathyroid Cancer, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to remove a parathyroid gland that is too large or has a tumor. These glands can be in different places, so doctors use an imaging scan with contrast dye to help find them before surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Hyperparathyroidism, Parathyroid Cancer, Multiple Endocrine Neoplasias
- What is being tested?
- 18F-FCH and NeuroEXPLORER
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to 5 Feb 2036
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Aged 18-100 years old
- Willing to have parathyroidectomy at NIH Clinical Center
- Meets one of the following:
- Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy.
- Diagnosed with any forms of heritable primary hyperparathyroidism (index presentation or recurrent disease) and is a potential candidate for parathyroidectomy. Participants clinically suspected of multi-gland disease (individuals with secondary/tertiary hyperparathyroidism) or germline predisposition PHPT syndrome are included in this cohort
- Suspected to have, or diagnosed with, parathyroid cancer and is a potential candidate for parathyroidectomy.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical.
- For persons able to become pregnant: unwilling to use highly effective contraception for at least two weeks prior to date of the first imaging scan through the date of the parathyroidectomy surgery
- Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan.
- Unable or unwilling to provide informed consent.
- Any other condition that would prevent the safe completion of study participation in the clinical opinion of the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
Lynn Bliss, (301) 435-7921, lynn.bliss@nih.gov
About this study
Official title: A Phase II Study of Accuracy of 18F-Fluorocholine PET/MRI and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Background:
People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to remove a parathyroid gland that is too large or has a tumor. These glands can be in different places, so doctors use an imaging scan with contrast dye to help find them before surgery. Researchers want to know if a different type of scan and a new tracer can make it easier to find the tumors in the parathyroid glands.
Read more
Objective:
To see if PET/MRI and NeuroEXPLORER PET-CT scans with a 18F-FCH tracer are better than existing methods for finding the parathyroid glands.
Eligibility:
People aged 18 years or older who are scheduled for surgery to remove a parathyroid gland.
Design:
Participants will have up to 4 clinic or hospital visits. They will be screened. They will have a physical exam and give blood samples.
Participants will have a 4-dimensional computed tomography (4D-CT) scan. This is the current way doctors look for parathyroid glands. They will be injected with an iodine-based dye for the 4D-CT scan. They will lie on a padded table that slides into a donut-shaped machine.
Participants will have a positron emission tomography (PET)-magnetic resonance imaging (MRI) and NeuroEXPLORER PET-CT scan. For these scans, they will be injected with a radioactive tracer (18F-FCH). They will wait about 30 to 60 minutes for their body to absorb the tracer. They will lie on a padded table that slides into a tube. Their vital signs will be monitored during the scan.
Participants will have surgery to remove the target gland. They may need to stay in the hospital for up to 3 nights.
Participants will have a follow-up visit 6 months after the surgery. This may be done remotely....
Read the detailed description
Study Description:
This study investigates the efficacy of 18F-FCH PET/ MRI and PET/CT for localization of parathyroid tumors in primary hyperparathyroidism (sporadic or heritable forms and parathyroid cancer).
Objectives:
Primary Objectives:
- Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
- Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT)
Secondary Objective:
- Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism
- Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT)
Endpoints:
Primary Endpoints:
- Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT).
- Positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT).
Secondary Endpoint:
- Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT
- Conditions
- Primary Hyperparathyroidism, Parathyroid Cancer, Multiple Endocrine Neoplasias, Heritable Hyperparathyroidism, Hyperparathyroid-jaw Tumor Syndrome
- Being tested
- 18F-FCH, NeuroEXPLORER
- Keywords
- Primary hyperparathyroidism, Parathyroid Cancer, MEN1, Heritable hyperparathyroidism, Hyperparathyroid-jaw tumor syndrome, Parathyroid adenomas
- Medical subject headings
- Hyperparathyroidism, Primary, Parathyroid Neoplasms, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FCHDrug
Radiotracer for use in PET/MRI and PET/CT
NeuroEXPLORERDevice
PET/CT machine
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | 18F-FCH injection for use in PET/CT and PET/MRI Receives: Drug: 18F-FCH; Device: NeuroEXPLORER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Biochemical cure in conjunction with histological findings is the standard endpoint to confirm cure. Positive Predictive Value (PPV) is defined as the ability to distinguish between a true positive and a false positive
Measured: Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Biochemical cure in conjunction with histological findings is the standard endpoint to confirm cure. Positive Predictive Value (PPV) is defined as the ability to distinguish between a true positive and a false positive when considering only positive diagnostic assessments. Positive Predictive Value would help in assessing frequency of false positives: Positive predictive value = true positive/ [true positives + false positives]
Measured: Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Secondary outcomes (1)
Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism (PHPT)
Will allow comparison of 18FFCH PET/MRI and PET/CT to conventional imaging.
Measured: Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start16 Apr 2026
- Primary completion5 Feb 2035 (estimated)
- Study completion5 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 193 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Smita Jha, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444723
- Sponsor's protocol ID
- 10002081
- Other IDs
- 002081-DK
- Status last verified
- 27 Oct 2026
- First submitted
- 2 Mar 2026
- Last updated
- 29 Oct 2026
- Results posted
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Accuracy of 18F-Fluorocholine PET/MRI and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
- ClinicalTrials.gov ID
- NCT07444723
- Acronym / sponsor ID
- 10002081
- Conditions
- Primary Hyperparathyroidism, Parathyroid Cancer, Multiple Endocrine Neoplasias, Heritable Hyperparathyroidism, Hyperparathyroid-jaw Tumor Syndrome
- Keywords
- Primary hyperparathyroidism, Parathyroid Cancer, MEN1, Heritable hyperparathyroidism, Hyperparathyroid-jaw tumor syndrome, Parathyroid adenomas
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 193 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 5 Feb 2035 (estimated)
- Study completion
- 5 Feb 2036 (estimated)
- First posted
- 3 Mar 2026 (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.
Background:
People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to remove a parathyroid gland that is too large or has a tumor. These glands can be in different places, so doctors use an imaging scan with contrast dye to help find them before surgery. Researchers want to know if a different type of scan and a new tracer can make it easier to find the tumors in the parathyroid glands.
Objective:
To see if PET/MRI and NeuroEXPLORER PET-CT scans with a 18F-FCH tracer are better than existing methods for finding the parathyroid glands.
Eligibility:
People aged 18 years or older who are scheduled for surgery to remove a parathyroid gland.
Design:
Participants will have up to 4 clinic or hospital visits. They will be screened. They will have a physical exam and give blood samples.
Participants will have a 4-dimensional computed tomography (4D-CT) scan. This is the current way doctors look for parathyroid glands. They will be injected with an iodine-based dye for the 4D-CT scan. They will lie on a padded table that slides into a donut-shaped machine.
Participants will have a positron emission tomography (PET)-magnetic resonance imaging (MRI) and NeuroEXPLORER PET-CT scan. For these scans, they will be injected with a radioactive tracer (18F-FCH). They will wait about 30 to 60 minutes for their body to absorb the tracer. They will lie on a padded table that slides into a tube. Their vital signs will be monitored during the scan.
Participants will have surgery to remove the target gland. They may need to stay in the hospital for up to 3 nights.
Participants will have a follow-up visit 6 months after the surgery. This may be done remotely....
Detailed description
Study Description:
This study investigates the efficacy of 18F-FCH PET/ MRI and PET/CT for localization of parathyroid tumors in primary hyperparathyroidism (sporadic or heritable forms and parathyroid cancer).
Objectives:
Primary Objectives:
- Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
- Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT)
Secondary Objective:
- Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism
- Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT)
Endpoints:
Primary Endpoints:
- Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT).
- Positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT).
Secondary Endpoint:
- Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: 18F-FCH, Device: NeuroEXPLORER18F-FCH injection for use in PET/CT and PET/MRI |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Aged 18-100 years old
- Willing to have parathyroidectomy at NIH Clinical Center
- Meets one of the following:
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical.
- For persons able to become pregnant: unwilling to use highly effective contraception for at least two weeks prior to date of the first imaging scan through the date of the parathyroidectomy surgery
- Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan.
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-FCHRadiotracer for use in PET/MRI and PET/CT | Drug | Single-Arm |
| NeuroEXPLORERPET/CT machine | Device | Single-Arm |
Primary outcome
Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Time frame: Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Biochemical cure in conjunction with histological findings is the standard endpoint to confirm cure. Positive Predictive Value (PPV) is defined as the ability to distinguish between a true positive and a false positive
Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Time frame: Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Biochemical cure in conjunction with histological findings is the standard endpoint to confirm cure. Positive Predictive Value (PPV) is defined as the ability to distinguish between a true positive and a false positive when considering only positive diagnostic assessments. Positive Predictive Value would help in assessing frequency of false positives: Positive predictive value = true positive/ [true positives + false positives]
1 secondary outcome
Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism (PHPT)
Time frame: Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- 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.
Smita Jha, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 18F-FCH and NeuroEXPLORER in people with Primary Hyperparathyroidism and Parathyroid Cancer, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Oct 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynn M Bliss ((301) 435-7921, lynn.bliss@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT) (time frame: Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)). 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 Oct 2026.