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

NCT04608253 | Completed

• 1 other identifier: 2018/658
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Hyperparathyroidism; Primary Hyperparathyroidism Due to Adenoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

11C-choline PET/CT DIAGNOSTIC_TEST

11C-choline PET/CT

All enrolled subjects received an 11C-choline PET/CT prior to enrollment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Parathyroid Neoplasms

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Adrienne Brouwers, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: October 29, 2020
• Study Start: January 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: August 1, 2020
• Last Updated: April 16, 2024

Record last verified: 2024-04