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NCT04608253 Clinical Trial

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

Primary Hyperparathyroidism Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04608253
Other study ID # 2018/658
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date August 1, 2020

Study information
Verified date April 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date August 1, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 11C-choline PET/CT
11C-choline PET/CT

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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