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

Not Applicable

Completed

• Conditions: Hyperparathyroidism; Parathyroid Adenoma
• Interventions: Diagnostic Test: We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism

• Registration Number: NCT04570033
• Lead Sponsor: Military Institute od Medicine National Research Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Study First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with hyperparathyroidism	We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism	We prospectively enrolled 65 consecutive patients with primary hyperparathyroidism (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

Primary Outcome Measures

Name	Time	Method
The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas	24 months	Sensitivity and positive predictive value of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism