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

Phase 1

Completed

• Conditions: Lung Cancer; Ovarian Cancer
• Interventions: 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

• Registration Number: NCT06386653
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

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. 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.

Study Timeline

• Study Start: 2024-04-14
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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
• Informed consent

Exclusion Criteria

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
• Informed consent

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer	Diagnostic injection of [123I]I-DARPIN-Ec1	At least five (5) evaluable subjects with lung cancer.
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer	Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1	At least five (5) evaluable subjects with lung cancer.
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer	Whole-body SPECT with [123I]I-DARPIN-Ec1	At least five (5) evaluable subjects with lung cancer.
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer	Diagnostic injection of [123I]I-DARPIN-Ec1	At least five (5) evaluable subjects with ovarian cancer.
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer	Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1	At least five (5) evaluable subjects with ovarian cancer.
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer	Whole-body SPECT with [123I]I-DARPIN-Ec1	At least five (5) evaluable subjects with ovarian cancer.

Primary Outcome Measures

Name	Time	Method
SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts)	6 hours	\[123I\]I-DARPIN-Ec1 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts)	6 hours	Focal uptake of \[123I\]I-DARPIN-Ec1 in the regions without pathological findings will be assessed with SPECT and measured in counts
Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%)	24 hours	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
Tumor-to-background ratio (SPECT)	6 hours	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)

Secondary Outcome Measures

Name	Time	Method
Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections.	24 hours	The safety attributable to \[123I\]I-DARPIN-Ec1 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)
Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections	24 hours	The safety attributable to \[123I\]I-DARPIN-Ec1 injections will be evaluated based on the rate of adverse events (percent)
Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections	24 hours	The safety attributable to \[123I\]I-DARPIN-Ec1 injections will be evaluated based on the rate of administration of concomitant medication (percent)
Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections.	24 hours	The safety attributable to \[123I\]I-DARPIN-Ec1 injections will be evaluated based on the assessments of physical examination, vital signs and ECG (percent of cases with abnormal findings relative to baseline).

Trial Locations

Locations (1)

TomskNRMC; 🇷🇺 Tomsk, Russian Federation