Back to resultsDiagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
Primary Purpose
Bone Metastases
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sodium Fluoride F-18 Injection
Technetium[99mTc] Methylenediphosphonate Injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Bone Metastases focused on measuring Lung Cancer, Breast Cancer, Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
18F-NaF-PET/CT
99mTc-MDP-BS±SPECT
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05614518
Brief Title
Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
June 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HTA Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases
Keywords
Lung Cancer, Breast Cancer, Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-NaF-PET/CT
Arm Type
Experimental
Arm Description
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
Arm Title
99mTc-MDP-BS±SPECT
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sodium Fluoride F-18 Injection
Other Intervention Name(s)
18F-NaF Injection
Intervention Description
Each subject was given 5-10 mCi intravenously. Images were collected 90-120 min after injection.
Intervention Type
Drug
Intervention Name(s)
Technetium[99mTc] Methylenediphosphonate Injection
Other Intervention Name(s)
99mTc-MDP Injection
Intervention Description
Each subject was given 10-25 mCi intravenously. Images were collected 3-6 hours after injection.
Primary Outcome Measure Information:
Title
Assess the sensitivity and specificity of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.
Description
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.
Time Frame
After the completion of two scanning imaging (or extended to 6 months).
Secondary Outcome Measure Information:
Title
Number of participants with adverse events as assessed by CTCAE v5.0.
Description
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.
Time Frame
From the first day of administration to the end of the trial.
Title
Assess the positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.
Description
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.
Time Frame
After the completion of two scanning imaging (or extended to 6 months).
Title
Assess the sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc⁃MDP-BS±SPECT based on lesions.
Description
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.
Time Frame
After the completion of two scanning imaging (or extended to 6 months).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
City
Peking
Country
China
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
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