drugset / Trial / NCT06101927
Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413
Phase 1
Completed
10 enrolled
Tomsk National Research Medical Center of the Russian Academy of Sciences
Uppsala University · collab
Non-randomizedParallel-groupSingle-blindDiagnostic
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.
Timeline
- Start
- 2023-10-19
- Primary completion
- 2024-05-31
- Completion
- 2024-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [99mTc]Tc-BQ0413 | Unknown | 50 ug | Intravenous |
| Subject | [99mTc]Tc-BQ0413 | Unknown | 100 ug | Intravenous |