NCT05614518

Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT

A Randomized, Open-Label, Crossover, Controlled, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases of Malignant Tumors Compared With 99mTc⁃MDP-BS±SPECT

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: HTA Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial was to assess the diagnostic performance and safety of Sodium Fluoride F-18 Positron Emission Tomography / Computed Tomography (18F-NaF-PET/CT) in bone metastases of malignant tumors compared with Technetium\[99mTc\] Methylenediphosphonate Bone Scintigraphy ± Single Photon Emission Computed Tomography (99mTc-MDP-BS±SPECT). The enrolled subjects were randomly assigned to two sequences A and B at a ratio of 1:1. Within 7 days, 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT bone imaging were performed alternately. The sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT were calculated respectively based on the diagnostic data of standard of truth.

Conditions

• Bone Metastases

Interventions

Type	Name	Description
DRUG	Sodium Fluoride F-18 Injection	Each subject was given 5-10 mCi intravenously. Images were collected 90-120 min after injection.
DRUG	Technetium[99mTc] Methylenediphosphonate Injection	Each subject was given 10-25 mCi intravenously. Images were collected 3-6 hours after injection.

Timeline

• Start date: 2021-03-29
• Primary completion: 2022-06-02
• Completion: 2022-06-02
• First posted: 2022-11-14
• Last updated: 2022-11-14

Locations

1 site across 1 country: China