Bone Metastases
Conditions
Keywords
Lung Cancer, Breast Cancer, Prostate Cancer
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.
Interventions
DRUGSodium Fluoride F-18 Injection
Each subject was given 5-10 mCi intravenously. Images were collected 90-120 min after injection.
DRUGTechnetium[99mTc] Methylenediphosphonate Injection
Each subject was given 10-25 mCi intravenously. Images were collected 3-6 hours after injection.
Sponsors
HTA Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
China
Outcome results
None listed