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| Name | Class |
|---|---|
| Uppsala University | OTHER |
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The study should evaluate the biological distribution of [99mTc]Tc-BQ0413 in patients with prostate cancer.
The primary objective are:
The secondary objective are:
1. To compare the obtained [99mTc]Tc- BQ0413 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer patients.
The overall goal is to study the effectiveness of SPECT imaging prostate cancer patients Using technetium-99m labeled BQ0413.
Phase I of the study:
Biodistribution of [99mTc]Tc-BQ0413 in patients with prostate 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 prostate cancer by SPECT using [99mTc]Tc-BQ0413 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 |
|---|---|---|---|
| Experimental: Prostate cancer 50 mkg | Experimental | At least five (5) evaluable subjects with prostate cancer with [99mTc]Tc-BQ0413 (50 mkg) |
|
| Experimental: Prostate cancer 100 mkg | Experimental | At leaAt least five (5) evaluable subjects with prostate cancer with [99mTc]Tc-BQ0413 (100 mkg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body study and SPECT with [99mTc]Tc-BQ0413 | Drug | One single intravenous injection of [99mTc]Tc-BQ0413, followed by gamma camera imaging after 2, 4, 6 and 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gamma camera-based whole-body [99mTc]Tc-BQ0413 uptake value (%) | Whole-body [99mTc]Tc-BQ0413 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 [99mTc]Tc-BQ0413 value in tumor lesions (counts) | [99mTc]Tc-BQ0413 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts | 6 hours |
| SPECT-based [99mTc]Tc-BQ0413 uptake value (counts) | Focal uptake of [99mTc]Tc-BQ0413 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 [99mTc]Tc-BQ0413 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-BQ0413 uptake coinciding with the regions without pathological findings (counts) | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of cases with abnormal findings relative to baseline [Safety and Tolerability] | The safety attributable to [99mTc]Tc-BQ0413 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:
Men
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir I Chernov, MD,Prof | Tomsk NRMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TomskNRMC | Tomsk | Russia |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Percent of participants with abnormal laboratory values that are related to diagnostic imaging procedure [Safety and Tolerability] |
The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline) |
| 24 hours |
| Percent of participants with adverse events that are related to diagnostic imaging procedure [Safety and Tolerability] | The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the rate of adverse events (percent) | 24 hours |
| Percent of participants requiring administration of medication due to side effects that are related to diagnostic imaging procedure [Safety and Tolerability] | The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the rate of administration of concomitant medication (percent) | 24 hours |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |