NCT06386653

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

SPECT Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1 in Lung and Ovarian Cancers 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: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Diagnostic injection of [123I]I-DARPIN-Ec1	A single intravenous injection of \[123I\]I-DARPIN-Ec1
DIAGNOSTIC_TEST	Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1	Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
DIAGNOSTIC_TEST	Whole-body SPECT with [123I]I-DARPIN-Ec1	Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1

Timeline

• Start date: 2024-04-14
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-04-26
• Last updated: 2025-04-09

Locations

1 site across 1 country: Russia