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The study should evaluate the biological distribution of 99mTc-HYNIC-FAPI in metastatic cancer patients.
The primary objective are:
The secondary objective are:
1. To compare the obtained [99mTc]Tc- HYNIC-FAPI SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in metastatic cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic cancer patients | Experimental | Metastatic cancer patients before starting chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [99mTc]Tc-HYNIC-FAPI | Drug | One single intravenous injection of [99mTc]Tc-HYNIC-FAPI, followed by gamma camera imaging after 2, 4, 6 and 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gamma camera-based whole-body [99mTc]Tc-HYNIC-FAPI uptake value (%). | Whole-body [99mTc]Tc-HYNIC-FAPI uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical. | 2, 4, 6 and 24 hours after injection. |
| SPECT/CT-based [99mTc]Tc-HYNIC-FAPI value in tumor lesions (counts and SUV) | 99mTc]Tc-HYNIC-FAPI uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts and SUV. | 2, 4 and 6 hours after injection. |
| SPECT/CT -based [99mTc]Tc-HYNIC-FAPI background uptake value (counts and SUV). | Focal uptake of [99mTc]Tc-HYNIC-FAPI in the regions without pathological findings will be assessed with SPECT/CT and measured in counts and SUV. | 2, 4 and 6 hours after injection. |
| Tumor-to-background ratio (SPECT/CT). | The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-HYNIC-FAPI uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-HYNIC-FAPI uptake coinciding with the regions without pathological findings (counts). | 2, 4 and 6 hours after injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal findings). | The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (Number of Participants with abnormal findings relative to baseline). | 2, 4, 6 and 24 hours after injection. |
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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 |
|---|---|---|---|---|---|---|
| Tomsk National Research Medical Center of the Russian Academy of Sciences | Tomsk | Tomsk Oblast | 634045 | Russia |
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The overall goal is to study the effectiveness of SPECT imaging Using technetium-99m labeled HYNIC-FAPI in metastatic cancer patients.
The main objectives of the study:
Additional research tasks:
To conduct a comparative analysis of the diagnostic information obtained in the visualization of metastatic cancer by SPECT using 99mTc-HYNIC-FAPI with data obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) research of postoperative material.
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| Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal laboratory findings). | The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the blood and urine laboratory tests (Number of Participants with abnormal laboratory findings relative to baseline). | 2, 4, 6 and 24 hours after injection. |
| Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with incidence of adverse events). | The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the rate of adverse events (Number of Participants). | 2, 4, 6 and 24 hours after injection. |
| Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with administration of concomitant medication). | The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the rate of administration of concomitant medication (Number of Participants). | 2, 4, 6 and 24 hours after injection. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D010190 | Pancreatic Neoplasms |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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