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

NCT06647966 | Not Yet Recruiting DMC

• 1 other identifier: CHOPET-HYPER
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Hyperparathyroidism

Outcome Measures

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.

  [11C]CH PET/CT : day 0

Study Arms (1)

Patients with clinical signs of hyperparathyroidism

Diagnostic Test: PET/CT

Interventions

PET/CT DIAGNOSTIC_TEST

\[11C\]CH PET/CT

Patients with clinical signs of hyperparathyroidism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or breast-feeding.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Arturo Chiti, MD

  IRCCS Ospedale San Raffaele

  STUDY DIRECTOR

Central Study Contacts

Lidija Antunovic Antunovic, MD

CONTACT

0226433639; antunovic.lidija@hsr.it

Alessandra Maielli, PhD

CONTACT

0226433639; maielli.alessandra@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)