drugset / Trial / NCT05614518
Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |