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Completed

NCT Number: NCT05614518

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

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.

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Key information

Conditions

Bone Metastases Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chinese Academy of Medical Sciences Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Sodium Fluoride F-18 Injection

Drug

Each subject was given 5-10 mCi intravenously. Images were collected 90-120 min after injection.

Other names: 18F-NaF Injection

Technetium[99mTc] Methylenediphosphonate Injection

Drug

Each subject was given 10-25 mCi intravenously. Images were collected 3-6 hours after injection.

Other names: 99mTc-MDP Injection

Primary outcomes

  1. Assess the sensitivity and specificity of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.

    Time frame: 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 outcomes

  1. Number of participants with adverse events as assessed by CTCAE v5.0.

    Time frame: 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.

  2. Assess the positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc-MDP-BS±SPECT based on subjects.

    Time frame: 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.

  3. Assess the sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT compared with 99mTc⁃MDP-BS±SPECT based on lesions.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HTA Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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