Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Key facts
- Who runs it
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 193 people, planned
- Started
- 16 Apr 2026
- Expected to end
- 5 Feb 2036
- Type of study
- Interventional
- Treatments tested
- 18F-FCH
- NeuroEXPLORER
- Record updated
- 29 October 2026
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who cannot take part
- 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
- Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical
- Any other condition that would prevent the safe completion of study participation in the clinical opinion of the investigators
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Unable or unwilling to provide informed consent
Other criteria
- INCLUSION CRITERIA:; 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: NIH Clinical Center Office of Patient Recruitment (OPR)Taking people
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
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....
The group in the trial
- Single-ArmTreatment being tested
18F-FCH injection for use in PET/CT and PET/MRI
Treatment: 18F-FCH and NeuroEXPLORER
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase II Study of Accuracy of 18F-Fluorocholine PET/MRI and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
- Fit questions
- Built from NCT07444723, who can take part
- Record updated
- 29 October 2026