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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism; Primary Hyperparathyroidism Due to Adenoma
• Intervention / Treatment: Diagnostic test: 11C-choline PET/CT

• Study Type: Observational
• Enrollment (Actual): 36

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective single-center cohort study of patients with biochemically proven pHPT who underwent parathyroid surgery after localization by means of 11C-choline PET/CT and negative or discordant first-line imaging in a teaching and tertiary referral hospital in the Netherlands between 2015 and 2019.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All enrolled subjects received an 11C-choline PET/CT prior to enrollment.; 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	Diagnostic test: 11C-choline PET/CT; 11C-choline PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of 11C-choline PET/CT	Per-lesion sensitivity of 11C-choline PET/CT for the detection of overactive parathyroid glands	Until 6 months after parathyroid surgery
Positive predictive value of 11C-choline PET/CT	Per-lesion positive predictive value of 11C-choline PET/CT for the detection of overactive parathyroid glands	Until 6 months after parathyroid surgery
Accuracy of 11C-choline PET/CT	Per-lesion accuracy of 11C-choline PET/CT for the detection of overactive parathyroid glands	Until 6 months after parathyroid surgery

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Adrienne Brouwers, MD PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary; Adenoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: 2018/658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Available upon reasonable request via the principle investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No