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| Name | Class |
|---|---|
| Uppsala University | OTHER |
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The study should evaluate the biological distribution of 99mTc-DB8 in patients with prostate cancer and breast cancer.
The primary objective are:
The secondary objective are:
1. To compare the obtained [99mTc]Tc- DB8 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer and breast cancer patients.
The overall goal is to study the effectiveness of SPECT imaging prostate cancer and breast cancer patients Using technetium-99m labeled DB8.
Phase I of the study:
Biodistribution of 99mTc-DB8 in patients with prostate cancer and breast 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 and breast cancer by SPECT using 99mTc-DB8 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 |
|---|---|---|---|
| Prostate cancer | Experimental | At least five (5) evaluable subjects with prostate cancer |
|
| Breast cancer | Experimental | At least five (5) evaluable subjects with breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous injection of [99mTc]Tc-DB8 | Drug | One single intravenous injection of [99mTc]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%) | Whole-body [99mTc]Tc-DB8 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-DB8 value in tumor lesions (counts) | [99mTc]Tc-DB8 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts | 6 hours |
| SPECT-based [99mTc]Tc-DB8 background uptake value (counts) | Focal uptake of [99mTc]Tc-DB8 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-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-DB8 uptake coinciding with the regions without pathological findings (counts) | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety attributable to [99mTc]Tc-DB8 injections (physical findings) | The safety attributable to [99mTc]Tc-DB8 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 |
| Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir I Chernov, MD,Prof | TomskNRMC Tomsk, Russia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TomskNRMC | Tomsk | Russia |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Parallel Assignment
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Single (Participant)
|
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline). |
| 24 hors |
| Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events) | The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of adverse events (percent). | 24 hours |
| Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication) | The safety attributable to [99mTc]Tc-DB8 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 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |