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

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614518
• Other study ID #: BJK-Z-F18HN-202010-YZGK
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2021
• Est. completion date: June 2, 2022

Study information

• Verified date: November 2022
• Source: HTA Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

1. Male or female, age 18 to 75 years, inclusive.

2. It is confirmed to be lung cancer, prostate cancer or breast cancer by combining medical history, imaging and pathological examination, and radionuclide bone imaging is required, and any one of the following is required:

1. Bone imaging within 3 months before the signing the ICF cannot exclude bone metastasis.

2. Associated with clinical manifestations related to bone metastasis, including bone pain, activity disorder, pathological fracture, spinal cord or spinal nerve compression symptoms, alkaline phosphatase elevation, hypercalcemia or Prostate Specific Antigen (PSA) >10 ng / ml.

3. Those with definite metastasis outside the primary tumor focus.

4. Patients with a history of bone metastasis.

5. Patients who need to confirm the status of bone metastasis for tumor staging.

3. According to the standard of the Eastern Cooperative Oncology Group (ECOG), the score was 0-1.

4. The expected survival of the Patients was > 6 months.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences Peking Union Medical College Hospital	Peking

Sponsors (1)

Lead Sponsor	Collaborator
HTA Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the sensitivity and specificity of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.	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.	After the completion of two scanning imaging (or extended to 6 months).
Secondary	Number of participants with adverse events as assessed by CTCAE v5.0.	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.	From the first day of administration to the end of the trial.
Secondary	Assess the positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.	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.	After the completion of two scanning imaging (or extended to 6 months).
Secondary	Assess the sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc?MDP-BS±SPECT based on lesions.	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.	After the completion of two scanning imaging (or extended to 6 months).