Breast Cancer (Locally Advanced or Metastatic), Colorectal Cancer (Locally Advanced or Metastatic), Lung Cancer (Locally Advanced or Metastatic), Pancreas Cancer, Metastatic
Conditions
Keywords
Metastatic cancer, Fibroblast Activation Protein, [99mTc]Tc-HYNIC-FAPI, SPECT/CT
Brief summary
The study should evaluate the biological distribution of 99mTc-HYNIC-FAPI in metastatic cancer patients.
Detailed description
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.
Interventions
DRUG[99mTc]Tc-HYNIC-FAPI
One single intravenous injection of \[99mTc\]Tc-HYNIC-FAPI, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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: 1. To evaluate the distribution of 99mTc-HYNIC-FAPI in normal tissues and tumors in metastatic cancer patients at different time intervals. 2. To evaluate dosimetry of 99mTc-HYNIC-FAPI based on the pharmacokinetic parameters of the drug after a single intravenous administration. 3. To study the safety of use and tolerability of the drug 99mTc-HYNIC-FAPI after a single intravenous administration in a diagnostic dosage. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gamma camera-based whole-body [99mTc]Tc-HYNIC-FAPI uptake value (%). | 2, 4, 6 and 24 hours after injection. | 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. |
| SPECT/CT-based [99mTc]Tc-HYNIC-FAPI value in tumor lesions (counts and SUV) | 2, 4 and 6 hours after injection. | 99mTc\]Tc-HYNIC-FAPI uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts and SUV. |
| SPECT/CT -based [99mTc]Tc-HYNIC-FAPI background uptake value (counts and SUV). | 2, 4 and 6 hours after injection. | 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. |
| Tumor-to-background ratio (SPECT/CT). | 2, 4 and 6 hours after injection. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal findings). | 2, 4, 6 and 24 hours after injection. | 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). |
| Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal laboratory findings). | 2, 4, 6 and 24 hours after injection. | 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). |
| Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with incidence of adverse events). | 2, 4, 6 and 24 hours after injection. | The safety attributable to \[99mTc\]Tc-HYNIC-FAPI injections will be evaluated based on the rate of adverse events (Number of Participants). |
| Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with administration of concomitant medication). | 2, 4, 6 and 24 hours after injection. | The safety attributable to \[99mTc\]Tc-HYNIC-FAPI injections will be evaluated based on the rate of administration of concomitant medication (Number of Participants). |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORVladimir I Chernov, MD, Prof.
TomskNRMC Tomsk, Russia
Outcome results
None listed