Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1

Status Enrolling by invitation

Clinical Trial Summary

The study should evaluate the biological distribution of [123I]I-DARPIN-Ec1 in patients with lung and ovarian cancer The primary objective are: 1. To assess the distribution of [123I]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of [123I]I-DARPIN-Ec1. 3. To study the safety and tolerability of the drug [123I]I-DARPIN-Ec1 after a single injection in a diagnostic dosage. The secondary objective are: 1. To compare the obtained [123I]I-DARPIN-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in lung and ovarian cancer patients.

Clinical Trial Description

The overall goal is to study the effectiveness of SPECT imaging lung and ovarian cancer using [123I]I-DARPIN-Ec1. Phase I of the study: Biodistribution of [123I]I-DARPIN-Ec1 in patients with lung and ovarian cancer . The main objectives of the study: 1. To evaluate the distribution of [123I]I-DARPIN-Ec1 in normal tissues and tumors in patients with lung and ovarian cancer at different time intervals. 2. To evaluate dosimetry of [123I]I-DARPIN-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 [123I]I-DARPIN-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 lung and ovarian cancer by SPECT using [123I]I-DARPIN-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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06386653
Study type	Interventional
Source	Tomsk National Research Medical Center of the Russian Academy of Sciences
Contact
Status	Enrolling by invitation
Phase	Phase 1
Start date	April 14, 2024
Completion date	December 31, 2024

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