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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
10
A single intravenous injection of \[123I\]I-DARPIN-Ec1
Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
TomskNRMC
Tomsk, Russia
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 6 hours
Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections.
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).
Time frame: 24 hours
Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections.
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)
Time frame: 24 hours
Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections
The safety attributable to \[123I\]I-DARPIN-Ec1 injections will be evaluated based on the rate of adverse events (percent)
Time frame: 24 hours
Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections
The safety attributable to \[123I\]I-DARPIN-Ec1 injections will be evaluated based on the rate of administration of concomitant medication (percent)
Time frame: 24 hours
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