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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bone Metastases

Intervention / Treatment
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* Drug: Sodium Fluoride F-18 Injection
* Drug: Technetium[99mTc] Methylenediphosphonate Injection


Participation Criteria
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Eligibility Criteria
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Male or female, age 18 to 75 years, inclusive. 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: Bone imaging within 3 months before the signing the ICF cannot exclude bone metastasis. 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. Those with definite metastasis outside the primary tumor focus. Patients with a history of bone metastasis. Patients who need to confirm the status of bone metastasis for tumor staging. According to the standard of the Eastern Cooperative Oncology Group (ECOG), the score was 0-1. The expected survival of the Patients was > 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-NaF-PET/CT<br>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 | Drug: Sodium Fluoride F-18 Injection<br>* Each subject was given 5-10 mCi intravenously. Images were collected 90-120 min after injection.<br>* Other names: 18F-NaF Injection;|
| Active Comparator: 99mTc-MDP-BS±SPECT<br>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 | Drug: Technetium[99mTc] Methylenediphosphonate Injection<br>* Each subject was given 10-25 mCi intravenously. Images were collected 3-6 hours after injection.<br>* Other names: 99mTc-MDP Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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). | 
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Lung Cancer, Prostate Cancer