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

Completed

• Conditions: Primary Hyperparathyroidism; Primary Hyperparathyroidism Due to Adenoma
• Interventions: Diagnostic Test: 11C-choline PET/CT

• Registration Number: NCT04608253
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-08-01
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-10-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All enrolled subjects received an 11C-choline PET/CT prior to enrollment.	11C-choline PET/CT	Patients with biochemically proven primary hyperparathyroidism who underwent parathyroid surgery after localization by means of 11C-choline PET/CT and negative or discordant first-line imaging

Primary Outcome Measures

Name	Time	Method
Accuracy of 11C-choline PET/CT	Until 6 months after parathyroid surgery	Per-lesion accuracy of 11C-choline PET/CT for the detection of overactive parathyroid glands
Sensitivity of 11C-choline PET/CT	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	Until 6 months after parathyroid surgery	Per-lesion positive predictive value of 11C-choline PET/CT for the detection of overactive parathyroid glands