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NCT Number: NCT06647966

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs San Raffaele

Milan, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • Pregnancy or breast-feeding.

Treatment and study plan

PET/CT

Diagnostic Test

[11C]CH PET/CT

Primary outcomes

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Maielli, PhD

CONTACT

[email protected]

0226433639

Lidija Antunovic Antunovic, MD

CONTACT

[email protected]

0226433639

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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