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Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06386653•Tomsk National Research Medical Center of the Russian Academy of Sciences

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is \> 18 years of age
•Clinical and radiological diagnosis of lung and ovarian cancer with histological verification.
•White blood cell count: \> 2.0 x 10\^9/L
•Haemoglobin: \> 80 g/L
•Platelets: \> 50.0 x 10\^9/L
•Bilirubin =\< 2.0 times Upper Limit of Normal
•Serum creatinine: Within Normal Limits
•Blood glucose level not more than 5.9 mmol/L
•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
•Subject is capable to undergo the diagnostic investigations to be performed in the study
+12 more criteria

Exclusion Criteria

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

Locations (1)

TomskNRMC

Tomsk, Russia

Key Dates

Start Date

April 14, 2024

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

April 9, 2025

Enrollment

ACTUAL participants

Conditions

Lung CancerOvarian Cancer

Interventions

Diagnostic injection of [123I]I-DARPIN-Ec1

DRUG

Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1

DIAGNOSTIC_TEST

Whole-body SPECT with [123I]I-DARPIN-Ec1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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