Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
NCT ID: NCT05614518
Last Updated: 2022-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2021-03-29
2022-06-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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18F-NaF-PET/CT
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
Sodium Fluoride F-18 Injection
Each subject was given 5-10 mCi intravenously. Images were collected 90-120 min after injection.
99mTc-MDP-BS±SPECT
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
Technetium[99mTc] Methylenediphosphonate Injection
Each subject was given 10-25 mCi intravenously. Images were collected 3-6 hours after injection.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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HTA Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Beijing, , China
Countries
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Other Identifiers
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BJK-Z-F18HN-202010-YZGK
Identifier Type: -
Identifier Source: org_study_id
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