molecular imaging of epcam receptors using [123i]i-darpin-ec1

Conditions: Lung Cancer; Ovarian Cancer

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.

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.

Eligibility 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: 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

Keywords: lung cancer оvarian cancer [123i]i-darpin-ec1 spect