Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07138820

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Proven primary hyperparathyroidism
  • Indication for surgery
  • Adults aged over 18 years
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Diagnostic Evaluation

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)

Treatment

Duration - Day of surgery

Participants receive parathyroidectomy surgery based on the imaging results to remove diseased parathyroid glands.

1 surgical visit (in-person)

Post-operative Follow-up

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

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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

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