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CompletedNCT04608253Updated Apr 16, 2024

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

An observational study in Primary Hyperparathyroidism and Primary Hyperparathyroidism Due to Adenoma, sponsored by University Medical Center Groningen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by University Medical Center Groningen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
36
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Primary Hyperparathyroidism
  • Primary Hyperparathyroidism Due to Adenoma
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In context

Hyperparathyroidism, Primary

105 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.

This study's enrollment of 36 is below the median of 145 across 42 observational studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 625 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
36 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic test11C-choline PET/CT

    11C-choline PET/CT

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What researchers measure

Primary outcomes

  1. Sensitivity of 11C-choline PET/CT

    Per-lesion sensitivity of 11C-choline PET/CT for the detection of overactive parathyroid glands

    Time frame: Until 6 months after parathyroid surgery

  2. 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

    Time frame: Until 6 months after parathyroid surgery

  3. Accuracy of 11C-choline PET/CT

    Per-lesion accuracy of 11C-choline PET/CT for the detection of overactive parathyroid glands

    Time frame: Until 6 months after parathyroid surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided — Available upon reasonable request via the principle investigator

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Dec 2019, 59 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2020
First posted
Oct 29, 2020
StartActual
Jan 1, 2015
Primary completionActual
Dec 31, 2019
CompletionActual
Aug 1, 2020
Last update
Apr 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04608253
Responsible party
Sponsor
First posted
Oct 29, 2020
Start date
Jan 1, 2015
Primary completion
Dec 31, 2019
Completion
Aug 1, 2020
Last update
Apr 16, 2024

Study contacts

Adrienne Brouwers, MD PhD
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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