Actively Recruiting
18F-choline-PET-CT vs Ultrasonography and 99-technetium Sestamibi Scintigraphy in Preoperative Localization for Primary Hyperparathyroidism - A Randomized Trial
Led by Region Skane · Updated on 2025-08-24
88
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether 18F-choline positron-emission-tomography computed tomography (18F-ch-PET-CT) is better than conventional imaging methods like ultrasonography and sestamibi scintigraphy at locating diseased parathyroid glands in adults with primary hyperparathyroidism (pHPT). The study aims to improve surgical precision, increase cure rates, reduce complications, and shorten operation times. Primary hyperparathyroidism causes problems like kidney stones and bone weakness because of enlarged parathyroid glands producing too much hormone. This open, randomized clinical trial compares two imaging approaches before surgery. One group receives 18F-ch-PET-CT imaging, while the other undergoes standard ultrasonography and sestamibi scintigraphy. Patients are randomly assigned to one of these groups. The study will measure how long the surgery takes and look at cure rates, complication rates, and the accuracy of each imaging method. The trial is conducted at a single center and does not involve blinding. Participants will have their imaging results and surgery details recorded. Researchers will monitor operation times from start to finish and evaluate cure by checking calcium levels one month after surgery. They will also track complications like nerve damage or persistent disease. Data are collected securely in a national registry. The study aims to include 100 participants and expects to complete analyses within a few years. Safety monitoring includes assessment of potential side effects from the imaging agents used.
CONDITIONS
Brief Title
18F-choline Positron-emission-tomography - Computed-tomography Compared to Conventional Imaging for Localizing Diseased Parathyroid Glands in Primary Hyperparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Proven primary hyperparathyroidism
- Indication for surgery
- Adults aged over 18 years
You will not qualify if you...
- Inability to give informed consent
- Allergy to contrast agents
- Pregnancy
- Breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 1 week
Participants undergo imaging with either 18F-choline-PET-CT or conventional imaging using ultrasonography and sestamibi scintigraphy to localize diseased parathyroid glands before surgery.
1 imaging visit (in-person)
Duration - Day of surgery
Participants receive parathyroidectomy surgery based on the imaging results to remove diseased parathyroid glands.
1 surgical visit (in-person)
Duration - Approximately 1 month
Participants are monitored for cure rates, complications, and persistent disease with a follow-up visit about one month after surgery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Skåne University Hospital
Lund, Sweden
Actively Recruiting
Research Team
M
Martin Almquist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here