drugset / Trial / NCT05614518

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

NCT05614518

Phase 3 Completed 280 enrolled HTA Co., Ltd.
RandomizedCrossoverOpen-labelDiagnostic

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.

Timeline

Start
2021-03-29
Primary completion
2022-06-02
Completion
2022-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Fluoride F-18 Diagnostic / imaging agent 185 mbq Intravenous
Subject Sodium Fluoride F-18 Diagnostic / imaging agent 370 mbq Intravenous
Comparator Technetium[99mTc] Methylenediphosphonate Diagnostic / imaging agent 370 mbq Intravenous
Comparator Technetium[99mTc] Methylenediphosphonate Diagnostic / imaging agent 925 mbq Intravenous