A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT in Primary Hyperparathyroidism

The leading cause of primary hyperparathyroidism (pHPT) is a solitary adenoma (89%). The treatment of pHPT is generally surgical removal of the overactive parathyroid gland(s). Since a solitary adenoma is the predominant cause, parathyroid surgery is preferably performed through a minimally invasive parathyroidectomy (MIP) in which only the suspected adenoma causing the pHPT is resected in a focused manner. To facilitate the performance of a MIP, accurate preoperative imaging is pivotal. This study aimed to analyze the diagnostic performance of 11C-choline PET/CT after prior negative or discordant first-line imaging in patients with pHPT undergoing parathyroid surgery with an optimized imaging protocol.

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Key information

Conditions

Primary Hyperparathyroidism Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hyperparathyroidism Hyperparathyroidism, Primary Neoplasms Neoplasms by Site Parathyroid Diseases Parathyroid Neoplasms Primary Hyperparathyroidism Due to Adenoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients eligible for inclusion were ≥18 years old, diagnosed with biochemically confirmed pHPT, underwent a MIBI-SPECT/CT and/or cUS with negative or discordant results, and underwent a 11C-choline PET/CT followed by parathyroidectomy.

Exclusion criteria

Patients were excluded if they were known to have a germline mutation predisposing for familial hypocalciuric hypercalcemia (FHH).

Treatment and study plan

11C-choline PET/CT

Diagnostic Test

11C-choline PET/CT

Primary outcomes

Sensitivity of 11C-choline PET/CT

Time frame: Until 6 months after parathyroid surgery

Per-lesion sensitivity of 11C-choline PET/CT for the detection of overactive parathyroid glands
Positive predictive value of 11C-choline PET/CT

Time frame: Until 6 months after parathyroid surgery

Per-lesion positive predictive value of 11C-choline PET/CT for the detection of overactive parathyroid glands
Accuracy of 11C-choline PET/CT

Time frame: Until 6 months after parathyroid surgery

Per-lesion accuracy of 11C-choline PET/CT for the detection of overactive parathyroid glands

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT for Detection of Hyperfunctioning Parathyroid Glands After Prior Negative or Discordant Imaging in Primary Hyperparathyroidism

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2020
First posted: Oct 29, 2020
Registry last updated: Apr 16, 2024

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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