Clinical Trial · NCT05620472

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

Overview

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.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Phase

Phase 1

Contacts

Vladimir I Chernov, MD, Prof (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05620472

Eligibility

Inclusion

Bilirubin =\< 2.0 times Upper Limit of Normal
Clinical and radiological diagnosis of solid tumor with histological verification.
A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
Haemoglobin: \> 80 g/L
Subject is capable to undergo the diagnostic investigations to be performed in the study
Blood glucose level not more than 5.9 mmol/L
Platelets: \> 50.0 x 10\^9/L
White blood cell count: \> 2.0 x 10\^9/L
Serum creatinine: Within Normal Limits

Exclusion

Active current autoimmune disease or history of autoimmune disease
Known HIV positive or chronically active hepatitis B or C
Administration of other investigational medicinal product within 30 days of screening
Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's