Lung Cancer, Ovarian Cancer
Conditions
Keywords
Lung cancer, Оvarian cancer, [123I]I-DARPIN-Ec1, SPECT
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.
Interventions
DRUGDiagnostic injection of [123I]I-DARPIN-Ec1
A single intravenous injection of \[123I\]I-DARPIN-Ec1
DIAGNOSTIC_TESTWhole-body planar scintigraphy with [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
DIAGNOSTIC_TESTWhole-body SPECT with [123I]I-DARPIN-Ec1
Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Uppsala University
The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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) |
Countries
Russia
Contacts
STUDY_DIRECTORVladimir I Chernov, MD, Prof
Oncology Research Institute of Tomsk NRMC
Outcome results
None listed