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Primary HyperparathyroidismNCT06647966

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

An observational study of Primary Hyperparathyroidism, run by IRCCS San Raffaele at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Hyperparathyroidism
What is being tested?
PET/CT
How many people
200 participants
Where
1 siteItaly
Study dates
Jan 2025to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Pregnancy or breast-feeding.

Trial locations and contacts

1 site in 1 country.

Lidija Antunovic Antunovic, MD contact

0226433639

antunovic.lidija@hsr.it

Alessandra Maielli, PhD contact

0226433639

maielli.alessandra@hsr.it

Italy1 site
  • Irccs San Raffaele

    Milan

Other trials in Italy

About this study

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.

Being tested
PET/CT
Medical subject headings
Hyperparathyroidism, Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET/CTDiagnostic test

    [11C]CH PET/CT

Study groups in NCT06647966
Study groupRoleWhat they receive
Patients with clinical signs of hyperparathyroidismNot described
Receives: Diagnostic Test: PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: [11C]CH PET/CT : day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647966
Sponsor's protocol ID
CHOPET-HYPER
Status last verified
Oct 2024
First submitted
16 Oct 2024
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Hyperparathyroidism, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lidija Antunovic Antunovic, MD (0226433639, antunovic.lidija@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the diagnostic performances of [11C]CH PET/CT in patients with biochemically proven HPT. (time frame: [11C]CH PET/CT : day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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