Glioma (Any Grade) in the Brain
Conditions
Keywords
Glioma patients, 99mTc-1-thio-D-glucose SPECT/CT, 18F-FET PET/CT
Brief summary
An open-label, single-center study with 99mTc-1-thio-D-glucose single photon emission computed tomography / computed tomography (SPECT/CT) and 18F-fluoroethyl-l-tyrosine (18F-FET) positron emission tomography / computed tomography (PET/CT) in primary and recurrent glioma patients, where the primary endpoint of the study is to compare imaging properties of 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT of brain tumor Imaging.
Detailed description
The primary objectives are: \- To compare 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT properties in primary and recurrent glioma patients The secondary objectives are: \- To compare the accumulation levels of 99mTc-1-thio-D-glucose and 18F-FET depending on the pathomorphological (biopsy/surgical material) and molecular genetic (Ki-67, isocitrate dehydrogenase 1/2 (IDH1/2) mutations, p53 expression) characteristics of the tumor.
Interventions
DRUG99mTc-1-thio-D-glucose
One single injection of 99mTc-1-thio-D-glucose, followed by SPECT/CT imaging 1 hour after injection.
DRUG18F-FET
One single injection of 18F-FET, followed by gamma camera imaging PET/CT 20 minutes after injection.
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
Single Group Assignment Diagnostic Test: 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT for brain tumor Imaging.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary and recurrent glioma; * Sequential injection of 99mTc-1-thio-D-glucose and 18F-FET in the interval of 14 days in each patient; * Hematological, liver and renal function test results within the following limits: * White blood cell count: \> 2.0 x 109/L * Hemoglobin: \> 80 g/L * Platelets: \> 50.0 x 109/L * Alanine aminotransferase (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 * A negative pregnancy test 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 99mTc-1-thio-D-glucose uptake in tumor (SUVmean) | 1 hour | SPECT/CT-based 99mTc-1-thio-D-glucose uptake value in primary or recurrent tumor lesions will be assessed at 1 hour after injection and measured in SUVmean. |
| 99mTc-1-thio-D-glucose uptake in background (SUVmean) | 1 hour | SPECT/CT-based 99mTc-1-thio-D-glucose uptake value in normal brain tissue will be assessed at 1 hour after injection and measured in SUVmean. |
| 99mTc-1-thio-D-glucose tumor-to-background ratio (SPECT/CT) | 1 hour | The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions (SUVmean) will be divided by the value of 99mTc-1-thio-D-glucose uptake coinciding with the brain regions without pathological findings (SUVmean). |
| Sensitivity of 99mTc-1-thio-D-glucose SPECT/CT (%) | 1 hour | Sensitivity (%) of the 99mTc-1-thio-D-glucose SPECT/CT will be assessed by comparing of cases with high 99mTc-1-thio-D-glucose uptake in the primary tumor with the positive for glioma results of immunohistochemical studies. |
| 18F-FET uptake in tumor (SUVmean) | 20 minutes | PET/CT-based 18F-FET uptake value in primary tumor lesions or in recurrent tumor lesions will be assessed at 20 minutes after injection and measured in SUVmean. |
| 18F-FET uptake in background (SUVmean) | 20 minutes | PET/CT-based 18F-FET uptake value in normal brain tissue will be assessed at 20 minutes after injection and measured in SUVmean. |
| 18F-FET tumor-to-background ratio (PET/CT) | 20 minutes | The PET/CT-based tumor-to-background ratio will be calculated as follows: the value of 18F-FET uptake coinciding with tumor lesions (SUVmean) will be divided by the value of 18F-FET uptake coinciding with the brain regions without pathological findings (SUVmean). |
| Sensitivity of 18F-FET PET/CT (%) | 20 minutes | Sensitivity (%) of the 18F-FET PET/CT will be assessed by comparing of cases with high 18F-FET uptake in the primary tumor with the positive for glioma results of immunohistochemical studies. |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORVladimir I Chernov, MD, Prof.
Tomsk National Research Medical Center of the Russian Academy of Sciences
Outcome results
None listed