drugset / Trial / NCT05620472
Molecular Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1
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(CO)3-(HE)3-Ec1 in patients with solid tumor The primary objective are: 1. To assess the distribution of \[99mTc\]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of \[99mTc\]Tc(CO)3-(HE)3-Ec1 . 3. To study the safety and tolerability of the drug \[99mTc\]Tc(CO)3-(HE)3-Ec1 after a single injection in a diagnostic dosage. The secondary objective are: 1\. To compare the obtained \[99mTc\]Tc(CO)3-(HE)3-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in solid tumor patients.
Timeline
- Start
- 2022-10-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [99mTc]Tc(CO)3-(HE)3-Ec1 | Diagnostic / imaging agent | 1000 ug | Intravenous |
| Subject | [99mTc]Tc(CO)3-(HE)3-Ec1 | Diagnostic / imaging agent | 2000 ug | Intravenous |
| Subject | [99mTc]Tc(CO)3-(HE)3-Ec1 | Diagnostic / imaging agent | 3000 ug | Intravenous |