Using 18F‑choline PET/CT versus ultrasound and sestamibi to locate diseased parathyroid glands
18F-choline-PET-CT vs Ultrasonography and 99-technetium Sestamibi Scintigraphy in Preoperative Localization for pHPT - A Randomized Trial
NA · Region Skane · NCT07138820
This trial tests whether 18F‑choline PET/CT can better locate diseased parathyroid glands than ultrasound and sestamibi scans in adults with primary hyperparathyroidism who are scheduled for surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Lund) |
| Trial ID | NCT07138820 on ClinicalTrials.gov |
What this trial studies
This is an open, single-center, prospective, randomized trial comparing 18F‑choline PET/CT to conventional preoperative imaging (neck ultrasonography and 99mTc‑sestamibi scintigraphy) for localization of abnormal parathyroid glands in primary hyperparathyroidism. Adult patients with confirmed pHPT and an indication for parathyroidectomy are randomized to receive either the 18F‑choline PET/CT imaging pathway or the conventional imaging pathway prior to surgery. The study will compare localization accuracy and downstream surgical outcomes such as cure rates, operation time, and complications. The goal is to determine whether more precise imaging can reduce the extent of dissection and improve surgical efficiency and outcomes.
Who should consider this trial
Good fit: Adults (over 18) with proven primary hyperparathyroidism who have an indication for parathyroidectomy and can give informed consent are the intended participants.
Not a fit: People who are pregnant or breastfeeding, those allergic to contrast, or those unable to give informed consent would be excluded and would not be eligible for benefit from this protocol.
Why it matters
Potential benefit: If successful, surgeons could locate and remove the abnormal gland(s) more precisely, which may increase cure rates, shorten operations, and reduce complications.
How similar studies have performed: Recent clinical reports and small series have shown promising results for 18F‑choline PET/CT with higher localization sensitivity than conventional imaging in many patients with pHPT.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Proven primary hyperparathyroidism Indication for surgery Adult (\>18 years) Exclusion Criteria: Inability to give informed consent Allergy to contrast Pregnancy and breastfeeding
Where this trial is running
Lund
- Skåne University Hospital — Lund, Sweden (RECRUITING)
Study contacts
- Study coordinator: Martin Almquist
- Email: martin.almquist@med.lu.se
- Phone: +46-46176245
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.
Conditions: Primary Hyperparathyroidism, surgery, positron emission tomography, scintigraphy, ultrasonography, primary hyperparathyroidism