18F‑Fluorocholine PET/MRI and NeuroEXPLORER PET/CT to locate parathyroid tumors
A Phase II Study of Accuracy of 18F-Fluorocholine PET/MRI and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
This trial will test whether 18F‑Fluorocholine PET/MRI and NeuroEXPLORER PET/CT scans can better find overactive or cancerous parathyroid glands in adults scheduled for surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 193 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT07444723 on ClinicalTrials.gov |
What this trial studies
Adults who are planning parathyroidectomy for primary or heritable hyperparathyroidism or suspected parathyroid cancer will receive 18F‑Fluorocholine PET/MRI and NeuroEXPLORER PET/CT scans in addition to the standard 4D‑CT imaging. The study compares the positive predictive value of the new PET techniques to 4D‑CT for locating abnormal parathyroid tissue. Participants will have screening visits, blood tests, and up to four clinic or hospital visits for imaging and surgical care at the NIH Clinical Center. Surgical findings will be used as the reference standard to determine how accurately each imaging method identified the abnormal glands.
Who should consider this trial
Good fit: Adults aged 18 or older who are candidates for parathyroidectomy for sporadic or heritable primary hyperparathyroidism, multi‑gland disease, or suspected parathyroid cancer are intended participants.
Not a fit: People who are pregnant or breastfeeding, have known allergies to the tracer components, cannot undergo PET/MRI or PET/CT, or are not planning surgery are unlikely to receive benefit from this study.
Why it matters
Potential benefit: If successful, these imaging methods could make it easier for surgeons to find abnormal parathyroid glands, potentially improving cure rates and reducing the extent or time of surgery.
How similar studies have performed: Smaller clinical studies have shown 18F‑Fluorocholine PET imaging often outperforms conventional scans for localizing parathyroid adenomas, while NeuroEXPLORER is a newer high‑sensitivity PET/CT platform with more limited published clinical data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Smita Jha, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Lynn M Bliss
- Email: lynn.bliss@nih.gov
- Phone: (301) 435-7921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.