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

November 7, 2022 updated by: HTA Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Peking, China
        • Chinese Academy of Medical Sciences Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Sodium Fluoride F-18 Injection
Each subject was given 5-10 mCi intravenously. Images were collected 90-120 min after injection.
Other Names:
  • 18F-NaF Injection
Active Comparator: 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
Drug: Technetium[99mTc] Methylenediphosphonate Injection
Each subject was given 10-25 mCi intravenously. Images were collected 3-6 hours after injection.
Other Names:
  • 99mTc-MDP Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After the completion of two scanning imaging (or extended to 6 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the first day of administration to the end of the trial.
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.
After the completion of two scanning imaging (or extended to 6 months).
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.
After the completion of two scanning imaging (or extended to 6 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HTA Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Actual)

June 2, 2022

Study Completion (Actual)

June 2, 2022

Study Registration Dates

First Submitted

October 30, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJK-Z-F18HN-202010-YZGK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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