NCT07444723 Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
| NCT ID | NCT07444723 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Condition | Primary Hyperparathyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 193 participants |
| Start Date | 2026-04-16 |
| Primary Completion | 2035-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 193 participants in total. It began in 2026-04-16 with a primary completion date of 2035-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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....
Eligibility Criteria
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: 1. Aged 18-100 years old 2. Willing to have parathyroidectomy at NIH Clinical Center 3. Meets one of the following: 1. Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy. 2. 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 3. Suspected to have, or diagnosed with, parathyroid cancer and is a potential candidate for parathyroidectomy. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnancy or lactation 2. Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical. 3. 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 4. Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan. 5. Unable or unwilling to provide informed consent. 6. Any other condition that would prevent the safe completion of study participation in the clinical opinion of the investigators.
Contact & Investigator
Smita Jha, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Frequently Asked Questions
Who can join the NCT07444723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Primary Hyperparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07444723 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07444723 currently recruiting?
Yes, NCT07444723 is actively recruiting participants. Contact the research team at lynn.bliss@nih.gov for enrollment information.
Where is the NCT07444723 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07444723 clinical trial?
NCT07444723 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The principal investigator is Smita Jha, M.D. at National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The trial plans to enroll 193 participants.