Skip to main content
OpenTrials
Completed

NCT Number: NCT04570033

The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas

We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism (PHPT).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperparathyroidism Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Parathyroid Adenoma Parathyroid Diseases Parathyroid Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primary hyperparathyroidism and neck US and the dual-phase 99mTc/99mTc-MIBI SPECT/CT scintigraphy performed prior to the PET/CT scan

Exclusion criteria

  • pregnancy
  • patient's lack of consent to the examination

Treatment and study plan

We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism

Diagnostic Test

We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.

Primary outcomes

  1. The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas

    Time frame: 24 months

    Sensitivity and positive predictive value of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Collaborators

  • Medical University of Warsaw

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2020
Registry last updated
Sep 30, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.