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

NCT06386653 | Completed Phase 1

• 1 other identifier: [123I]I-DARPIN-Ec1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 1.To assess the distribution of \[123I\]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals.
2. 2.To evaluate dosimetry of \[123I\]I-DARPIN-Ec1.
3. 3.To study the safety and tolerability of the drug \[123I\]I-DARPIN-Ec1 after a single injection in a diagnostic dosage.

Conditions

Lung Cancer; Ovarian Cancer

Keywords

Lung cancer; Оvarian cancer; [123I]I-DARPIN-Ec1; SPECT

Outcome Measures

Primary Outcomes (4)

• Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%)

  Whole-body \[123I\]I-DARPIN-Ec1 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical

  24 hours

• SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts)

  \[123I\]I-DARPIN-Ec1 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

  6 hours

• SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts)

  Focal uptake of \[123I\]I-DARPIN-Ec1 in the regions without pathological findings will be assessed with SPECT and measured in counts

  6 hours

• Tumor-to-background ratio (SPECT)

  The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \[123I\]I-DARPIN-Ec1 uptake coinciding with tumor lesions (counts) will be divided by the value of \[123I\]I-DARPIN-Ec1 uptake coinciding with the regions without pathological findings (counts)

  6 hours

Secondary Outcomes (4)

• Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections.

  24 hours

• Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections.

  24 hours

• Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections

  24 hours

• Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections

  24 hours

Study Arms (2)

Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer

EXPERIMENTAL

At least five (5) evaluable subjects with lung cancer.

Drug: Diagnostic injection of [123I]I-DARPIN-Ec1; Diagnostic Test: Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1; Diagnostic Test: Whole-body SPECT with [123I]I-DARPIN-Ec1

Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer

EXPERIMENTAL

At least five (5) evaluable subjects with ovarian cancer.

Drug: Diagnostic injection of [123I]I-DARPIN-Ec1; Diagnostic Test: Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1; Diagnostic Test: Whole-body SPECT with [123I]I-DARPIN-Ec1

Interventions

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

A single intravenous injection of \[123I\]I-DARPIN-Ec1

Also known as: [123I]I-DARPIN-Ec1 injection

Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer; Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer

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

Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1

Also known as: [123I]I-DARPIN-Ec1 scintigraphy

Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer; Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer

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

Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1

Also known as: [123I]I-DARPIN-Ec1 SPECT

Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer; Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Informed consent

You may not qualify if:

• 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
• Informed consent
• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead
• Uppsala University: collaborator
• The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry: collaborator

Study Sites (1)

TomskNRMC

Tomsk, Russia

Location

MeSH Terms

Conditions

Lung Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Vladimir I Chernov, MD, Prof

  Oncology Research Institute of Tomsk NRMC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: April 14, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Three years after completions of the study.
• Access Criteria: Review of requester's application submitted to the Principal Investigator.

Locations

RU (1)