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

NCT05614518 | Completed Phase 3

• 1 other identifier: BJK-Z-F18HN-202010-YZGK
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases

Keywords

Lung Cancer; Breast Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  After the completion of two scanning imaging (or extended to 6 months).

Secondary Outcomes (3)

• Number of participants with adverse events as 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.

  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.

  After the completion of two scanning imaging (or extended to 6 months).

Study Arms (2)

18F-NaF-PET/CT

EXPERIMENTAL

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

99mTc-MDP-BS±SPECT

ACTIVE COMPARATOR

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

Interventions

Sodium Fluoride F-18 Injection DRUG

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

Also known as: 18F-NaF Injection

18F-NaF-PET/CT

Technetium[99mTc] Methylenediphosphonate Injection DRUG

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

Also known as: 99mTc-MDP Injection

99mTc-MDP-BS±SPECT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• HTA Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Prostatic Neoplasms

Interventions

Technetium Tc 99m Medronate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organotechnetium Compounds; Organometallic Compounds; Organic Chemicals; Diphosphonates; Organophosphonates; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 14, 2022
• Study Start: March 29, 2021
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CN (1)