The study should evaluate the biological distribution of 99mTc-HYNIC-FAPI in metastatic cancer patients.
The primary objective are: 1. To assess the distribution of \[99mTc\]Tc- HYNIC-FAPI in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of \[99mTc\]Tc- HYNIC-FAPI. 3. To study the safety and tolerability of the drug \[99mTc\]Tc- HYNIC-FAPI after a single injection in a diagnostic dosage. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
One single intravenous injection of \[99mTc\]Tc-HYNIC-FAPI, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, Tomsk Oblast, Russia
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 2, 4 and 6 hours after injection.
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).
Time frame: 2, 4, 6 and 24 hours after injection.
Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal laboratory findings).
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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).
Time frame: 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).
Time frame: 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).
Time frame: 2, 4, 6 and 24 hours after injection.