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

HTA Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Bone Metastases

Treatments: Drug: Sodium Fluoride F-18 Injection; Drug: Technetium[99mTc] Methylenediphosphonate Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05614518

BJK-Z-F18HN-202010-YZGK

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

18F-NaF-PET/CT

Experimental group

Description:

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

Treatment:

Drug: Sodium Fluoride F-18 Injection

99mTc-MDP-BS±SPECT

Active Comparator group

Description:

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

Treatment:

Drug: Technetium[99mTc] Methylenediphosphonate Injection