Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Tomsk National Research Medical Center of the Russian Academy of Sciences
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject is \> 18 years of age
Clinical and radiological diagnosis of metastatic cancer with histological verification.
White blood cell count: \> 2.0 x 10\^9/L
Haemoglobin: \> 80 g/L
Platelets: \> 50.0 x 10\^9/L
Bilirubin =\< 2.0 times Upper Limit of Normal
Serum creatinine: Within Normal Limits
Blood glucose level not more than 5.9 mmol/L
A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
Subject is capable to undergo the diagnostic investigations to be performed in the study
Informed consent
You may not be if
Active current autoimmune disease or history of autoimmune disease
Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
Known HIV positive or chronically active hepatitis B or C
Administration of other investigational medicinal product within 30 days of screening
Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Clareo Health | Molecular Imaging of Fibroblast Activation Protein Expression Using Labeled Technetium-99m HYNIC-FAPI
