drugset / Trial / NCT05620472

Molecular Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1

NCT05620472 ↗

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

EvaluationDrugModalityDoseRoute
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

Indications