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

NCT06386653 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Vladimir I Chernov, MD, Prof · Oncology Research Institute of Tomsk NRMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-14
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06386653 on ClinicalTrials.gov