Clinical trial NCT05614518: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bone Metastases
Keywords: Lung Cancer
Breast Cancer
Prostate Cancer
Lead sponsor: HTA Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Assess the sensitivity and specificity of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.
timeFrame: After the completion of two scanning imaging (or extended to 6 months).
Secondary outcomes:
measure: Number of participants with adverse events as assessed by CTCAE v5.0.
timeFrame: From the first day of administration to the end of the trial.
measure: Assess the positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.
timeFrame: After the completion of two scanning imaging (or extended to 6 months).
measure: Assess the sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc⁃MDP-BS±SPECT based on lesions.
timeFrame: After the completion of two scanning imaging (or extended to 6 months).
Other outcomes:
Locations:
city: Peking
country: China
facility: Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Study officials:
References: