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| Name | Class |
|---|---|
| Uppsala University | OTHER |
| The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry | UNKNOWN |
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The study should evaluate the biological distribution of [123I]I-DARPIN-Ec1 in patients with lung and ovarian cancer
The primary objective are:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer | Experimental | At least five (5) evaluable subjects with lung cancer. |
|
| Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer | Experimental | At least five (5) evaluable subjects with ovarian cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic injection of [123I]I-DARPIN-Ec1 | Drug | A single intravenous injection of [123I]I-DARPIN-Ec1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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) | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir I Chernov, MD, Prof | Oncology Research Institute of Tomsk NRMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TomskNRMC | Tomsk | Russia |
IPD may be shared on request after consideration of requester's application.
Three years after completions of the study.
Review of requester's application submitted to the Principal Investigator.
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|
| Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1 | Diagnostic Test | 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 with [123I]I-DARPIN-Ec1 | Diagnostic Test | Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of [123I]I-DARPIN-Ec1 |
|
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| 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) | 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) | 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) | 24 hours |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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