Neoplasms Clinical Trial
Official title:
SPECT Imaging of Brain Tumors Using Technetium-99m Labeled 1-Thio-D-Glucose (99mTc-1-thio-D-glucose).
The study should evaluate the biological distribution of 99mTc-1-thio-D-glucose in patients with primary brain tumors and recurrence of brain tumors. The primary objective are: 1. To assess the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of 99mTc-1-thio-D-glucose. 3. To study the safety and tolerability of the drug 99mTc-1-thio-D-glucose after a single injection in a diagnostic dosage. The secondary objective are: 1. To compare the obtained SPECT imaging results of brain tumors with the data of magnetic resonance imaging (MRI) and/or positron emission tomography (PET) and immunohistochemical (IHC) studies of postoperative material.
Status | Completed |
Enrollment | 16 |
Est. completion date | February 15, 2021 |
Est. primary completion date | February 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Subject is > 18 years of age - Clinical and radiological diagnosis of a primary brain tumor or recurrence of a brain tumor with immunohistological verification. - Clinical and radiological diagnosis of a benign intracranial lesions. - White blood cell count: > 2.0 x 10^9/L - Haemoglobin: > 80 g/L - Platelets: > 50.0 x 10^9/L - alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST): =< 5.0 times Upper Limit of Normal - 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: - Second, non-brain malignancy - 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-1-thio-D-glucose uptake value (percent) | Whole-body 99mTc-1-thio-D-glucose uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (percent) of the injected dose of the radiopharmaceutical | 24 hours | |
Primary | SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts) | 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts | 6 hours | |
Primary | SPECT-based 99mTc-1-thio-D-glucose uptake value (counts) | Focal uptake of 99mTc-1-thio-D-glucose in the regions without pathological findings will be assessed with SPECT and measured in counts | 6 hours | |
Primary | Tumor-to-background ratio (unitless value) | The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-1-thio-D-glucose uptake coinciding with the regions without pathological findings (counts) | 6 hours | |
Secondary | Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal physical findings (percent) | The safety attributable to 99mTc-1-thio-D-glucose 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-1-thio-D-glucose injections, based on the rate of abnormal laboratory results (percent) | The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline) | 24 hours | |
Secondary | Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of adverse events (percent) | The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of adverse events (percent) | 24 hours | |
Secondary | Safety attributable to 99mTc-1-thio-D-glucose injections, based on the need for concomitant medication (percent) | The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of administration of concomitant medication (percent) | 24 hours |
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