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Not yet recruitingNCT06647966Updated Oct 22, 2024

Diagnostic Performance of [11C]Choline PET/CT In the Preoperative Assessment of Primary Hyperparathyroidism

An observational study in Primary Hyperparathyroidism, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Primary hyperparathyroidism (HPT) ranks as the third most common endocrine disorder, characterized by excessive secretion of parathormone (PTH), a hormone crucial for regulating calcium and phosphorus metabolism within the body. The only cure for HPT is surgically removing the hyperfunctioning parathyroid tissue, both in symptomatic and asymptomatic settings. With the advance of preoperative medical imaging techniques, a paradigm shift has taken place in the surgical approach of this condition, evolving from an inpatient bilateral cervical exploration to an outpatient minimally invasive procedure, which has proved to be superior in outcome. Due to the small size of the glands, preoperative visualisation and localisation are mandatory for the surgeon. Several imaging methods have been researched for identifying hyperfunctioning parathyroid glands, including morphological, functional and hybrid techniques, with no clear agreement on the optimal imaging approach.The preoperative localization modalities available are ultrasonography; parathyroid scintigraphy using technetium [99mTc]Tc sestamibi (MIBI), multiphase multidetector 4D computed tomography (4DCT); magnetic resonance imaging; and recently, positron-emission tomography/computed tomography (PET/CT) using 11C- and 18F-labelled radiotracers. While ultrasound and [99mTc]Tc-MIBI scintigraphy have been long used to diagnose and monitor patients with HPT, they can lead to numerous false negative results and therefore require additional examinations.Choline PET/CT is steadily replacing conventional imaging in many centres, allowing for the localization of adenomas in three quarter of patients with negative previous imaging examinations, but is still considered a relatively new method. [11C]C-Choline ([11C]CH) PET/CT is gradually gaining ground as a reliable method of localising HPT preoperatively, due to its fast uptake in hyperfunctioning parathyroid tissue, shorter acquisition time and lower radiation exposure compared to other nuclear medicine investigations and conventional methods. [11C]CH PET/CT has been suggested to be superior in diagnostic performances, compared to other imaging methods, reaching sensitivities up to 98.9%.The aim of our retrospective, single centre study is to evaluate the diagnostic performances and the inter-observer agreement of [11C]CH PET/CT for the preoperative detection of parathyroid adenomas in patients with suspected primary HPT.

02

Conditions studied

  • Primary Hyperparathyroidism
03

In context

Hyperparathyroidism, Primary

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

This study's planned enrollment of 200 is above the median of 130 across 40 observational studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Retrospectively select patients who performed PET in our institution from 2022 until 2024.

Patients who meet the following criteria will be included in the study.

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 with biochemically proven HPT, either through elevated serum levels of PTH or normal PTH despite hypercalcemia;
  • Age ≥ 18 years old;
  • [11C]CH PET/CT for HPT before eventual surgery.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breast-feeding.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with clinical signs of hyperparathyroidism

    Diagnostic Test: PET/CT

Interventions

  • Diagnostic testPET/CT

    \[11C\]CH PET/CT

06

What researchers measure

Primary outcomes

  1. To evaluate the diagnostic performances of [11C]CH PET/CT in patients with biochemically proven HPT.

    Calculation of diagnostic performance parameters: sensitivity, specificity, accuracy, positive and negative predictive values.

    Time frame: [11C]CH PET/CT : day 0

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for Dec 2025, 11 months later.

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

Registered
Oct 16, 2024
First posted
Oct 18, 2024
StartEst.
Jan 2025
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Oct 22, 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 Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06647966
Lead sponsor
IRCCS San Raffaele
Responsible party
Chiti Arturo (Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele, IRCCS San Raffaele) — Principal investigator
First posted
Oct 18, 2024
Start date
Jan 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Oct 22, 2024

Study contacts

Lidija Antunovic Antunovic, MD
Contact
antunovic.lidija@hsr.it
0226433639
Alessandra Maielli, PhD
Contact
maielli.alessandra@hsr.it
0226433639
Arturo Chiti, MD
study director · IRCCS Ospedale San Raffaele

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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