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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT04608253

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperparathyroidism Primary Hyperparathyroidism Due to Adenoma	Diagnostic Test: 11C-choline PET/CT

Study Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Center Groningen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Schelto Kruijff, MD PhD, Dr., University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT04608253

Other Study ID Numbers:

2018/658

First Posted:

Oct 29, 2020

Last Update Posted:

Oct 29, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenoma

Hyperparathyroidism

Hyperparathyroidism, Primary

Choline

Study Results

No Results Posted as of Oct 29, 2020