drugset / Trial / NCT06386653
Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1
Phase 1
Completed
10 enrolled
Tomsk National Research Medical Center of the Russian Academy of Sciences
The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry · collabUppsala University · collab
Non-randomizedParallel-groupSingle-blindDiagnostic
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.
Timeline
- Start
- 2024-04-14
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [123I]I-DARPIN-Ec1 | Unknown | — | Intravenous |