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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status and phase: Completed; Phase 1

Conditions: Lung Cancer; Ovarian Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06386653

[123I]I-DARPIN-Ec1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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 group

Description:

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

Treatment:

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