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

Phase 3

Completed

• Conditions: Bone Metastases
• Interventions: Drug: Technetium[99mTc] Methylenediphosphonate Injection; Drug: Sodium Fluoride F-18 Injection

• Registration Number: NCT05614518
• Lead Sponsor: HTA Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-29
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02
• Study First Submitted: 2022-10-30
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-07
• Last Update Submitted: 2022-11-07
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
99mTc-MDP-BS±SPECT	Technetium[99mTc] Methylenediphosphonate Injection	Patients undergo an 18F-NaF-PET/CT scan and an 99mTc-MDP-BS±SPECT scan within a time frame of 7 days. Generic Name: Technetium\[99mTc\] Methylenediphosphonate Injection Dosage Form: Injection Dosage: Administer 10-25 mCi as an intravenous injection Frequency and Duration: Single dose
18F-NaF-PET/CT	Sodium Fluoride F-18 Injection	Patients undergo an 18F-NaF-PET/CT scan and an 99mTc-MDP-BS±SPECT scan within a time frame of 7 days. Generic Name: Sodium Fluoride F-18 injection Dosage Form: Injection Dosage: Administer 5-10 mCi as an intravenous injection Frequency and Duration: Single dose

Primary Outcome Measures

Name	Time	Method
Assess the sensitivity and specificity of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.	After the completion of two scanning imaging (or extended to 6 months).	The sensitivity and specificity of 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT were calculated respectively based on subjects according to Standard of Truth.

Secondary Outcome Measures

Name	Time	Method
Assess the positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.	After the completion of two scanning imaging (or extended to 6 months).	The 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.
Number of participants with adverse events as assessed by CTCAE v5.0.	From the first day of administration to the end of the trial.	Any adverse events were recorded from the first day of administration to the end of the trial. Adverse events were assessed by CTCAE v5.0.
Assess the sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc⁃MDP-BS±SPECT based on lesions.	After the completion of two scanning imaging (or extended to 6 months).	The sensitivity and specificity of 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT were calculated respectively based on lesions according to Standard of Truth.

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences Peking Union Medical College Hospital; 🇨🇳 Peking, China