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NCT Number: NCT06804681

Is Intraoperative PTH Monitoring Obsolete in Times of Choline PET/CT? a Prospective Multicenter Cohort Study to Determine Whether the Regular Preoperative Use of Choline-PET/CT Scan Obviate the Need for Intraoperative PTH-measurement in Patients with Primary Hyperparathyreoidism

In patients with primary hyperparathyreoidism (pHPT) in 80-90% only one of the four parathyroid glands has developed an autonomy and is causative for the disease. Localisation diagnostics are used to help identify the affected gland or glands in order to enable more focused surgical approaches and reduce morbidity of the surgery, as well as operative time. The gold standard for imaging in Germany and Austria are sonography and scintigraphy. If imaging is not conclusive, Choline-PET/CT, which has been shown to have a higher specificity than the scintigraphy, especially for multiglandular disease, is performed mostly in Austria, but only on special indications in Germany. In Switzerland, as of 2023 the Choline-PET/CT has replaced the scintigraphy and is routinely performed in patients with indication for parathyroidectomy in many hospitals.

The current S2k guideline recommends to perform an intraoperative PTH measurement before and 10 minutes after removal of the parathyroid gland in order to assess the success of the surgery. Due to the short half-life of PTH of around three minutes, a PTH drop of 50% or into the normal range within 10 minutes of removal of the suspected gland has a high sensitivity and specificity for cure. If PTH drop is inadequate, further gland exploration is performed. The intraoperative measurement of PTH is associated with waiting time in the OR and uncertainty if the next patient can be anesthetized, prolonging surgeries by 30-60 minutes depending on the local facilities. If the Choline-PET/CT is sufficiently sensitive and specific in detecting both uni- and multiglandular disease, surgery according to Choline-PET/CT findings could make waiting for intraoperative PTH drop unnecessary.

The aim of the study is to determine whether the regular use of Choline-PET/CT can obviate the need for intraoperative PTH-measurement with the potential to shorten the length of parathyroid surgeries. This could save considerable costs and justify the regular use of Choline-PET/CT.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pHPT, preoperative Choline-PET, intraoperative PTH

Exclusion criteria

  • no consent

Treatment and study plan

Primary outcomes

  1. Determine the successful removal of all parathyroid glands responsible for the pHPT based on the preoperative Choline-PET/CT findings with measurement of parathormone and calcium level

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Vetter

CONTACT

[email protected]

+41432538147

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Is Intraoperative PTH Monitoring Obsolete in Times of Choline PET/CT?

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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