NCT06101927

Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413

SPECT Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413 ([99mTc]Tc- BQ0413) in Prostate Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study should evaluate the biological distribution of \[99mTc\]Tc-BQ0413 in patients with prostate cancer. The primary objective are: 1. To assess the distribution of \[99mTc\]Tc- BQ0413 in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of \[99mTc\]Tc- BQ0413. 3. To study the safety and tolerability of the drug \[99mTc\]Tc- BQ0413 after a single injection in a diagnostic dosage. The secondary objective are: 1\. To compare the obtained \[99mTc\]Tc- BQ0413 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer patients.

Detailed description

The overall goal is to study the effectiveness of SPECT imaging prostate cancer patients Using technetium-99m labeled BQ0413. Phase I of the study: Biodistribution of \[99mTc\]Tc-BQ0413 in patients with prostate cancer. The main objectives of the study: 1. To evaluate the distribution of \[99mTc\]Tc-BQ0413 in normal tissues and tumors in patients with prostate cancer at different time intervals. 2. To evaluate dosimetry of \[99mTc\]Tc-BQ0413 based on the pharmacokinetic parameters of the drug after a single intravenous administration. 3. To study the safety of use and tolerability of the drug \[99mTc\]Tc-BQ0413 after a single intravenous administration in a diagnostic dosage. Additional research tasks: 1\. To conduct a comparative analysis of the diagnostic information obtained in the visualization of prostate cancer by SPECT using \[99mTc\]Tc-BQ0413 with data obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) research of postoperative material. Methodology: Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Whole body study and SPECT with [99mTc]Tc-BQ0413	One single intravenous injection of \[99mTc\]Tc-BQ0413, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Timeline

• Start date: 2023-10-19
• Primary completion: 2024-05-31
• Completion: 2024-12-30
• First posted: 2023-10-26
• Last updated: 2025-04-09

Locations

1 site across 1 country: Russia