NCT05620472

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

SPECT Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1 in Solid Tumors 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: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The overall goal is to study the effectiveness of SPECT imaging solid tumor patients using \[99mTc\]Tc(CO)3-(HE)3-Ec1. Phase I of the study: Biodistribution of \[99mTc\]Tc(CO)3-(HE)3-Ec1 in patients with solid tumor. The main objectives of the study: 1. To evaluate the distribution of \[99mTc\]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors in patients with solid tumor at different time intervals. 2. To evaluate dosimetry of \[99mTc\]Tc(CO)3-(HE)3-Ec1 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(CO)3-(HE)3-Ec1 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 solid tumor by SPECT using \[99mTc\]Tc(CO)3-(HE)3-Ec1 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

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1	One single intravenous injection of \[99mTc\]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-11-17
• Last updated: 2025-04-09

Locations

1 site across 1 country: Russia