Breast Cancer Clinical Trial
Official title:
SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8 ([99mTc]Tc- DB8) in Prostate Cancer and Breast Cancer Patients
The study should evaluate the biological distribution of 99mTc-DB8 in patients with prostate cancer and breast cancer. The primary objective are: 1. To assess the distribution of [99mTc]Tc- DB8 in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of [99mTc]Tc- DB8. 3. To study the safety and tolerability of the drug [99mTc]Tc- DB8 after a single injection in a diagnostic dosage. 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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | July 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Subject is > 18 years of age - Clinical and radiological diagnosis of prostate cancer and breast 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | TomskNRMC | Tomsk |
Lead Sponsor | Collaborator |
---|---|
Tomsk National Research Medical Center of the Russian Academy of Sciences | Uppsala University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests) | 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 | |
Secondary | 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 | |
Secondary | 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 |
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