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
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.
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 →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
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Diagnostic Test: PET/CT
\[11C\]CH PET/CT
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
Plan to share: No
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Start is estimated for Jan 2025; primary completion for Dec 2025, 11 months later.
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Hyperparathyroidism, Primary →