Molecular Imaging of Brain Tumor Using 99mTc-1-thio-D-glucose SPECT/CT and 18F-Fluoroethyl-l-tyrosine PET/CT in Primary and Recurrent Glioma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 99mTc-1-thio-D-glucose uptake in tumor (SUVmean)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Primary and recurrent glioma patients.
Maximum (40) evaluable subjects with primary and recurrent glioma have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced
Intervention: 99mTc-1-thio-D-glucose (Drug)
Primary and recurrent glioma patients.
Maximum (40) evaluable subjects with primary and recurrent glioma have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced
Intervention: 18F-FET (Drug)
Outcomes
Primary Outcomes
99mTc-1-thio-D-glucose uptake in tumor (SUVmean)
Time Frame: 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 tumor-to-background ratio (SPECT/CT)
Time Frame: 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).
18F-FET uptake in tumor (SUVmean)
Time Frame: 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 tumor-to-background ratio (PET/CT)
Time Frame: 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 99mTc-1-thio-D-glucose SPECT/CT (%)
Time Frame: 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.
99mTc-1-thio-D-glucose uptake in background (SUVmean)
Time Frame: 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.
18F-FET uptake in background (SUVmean)
Time Frame: 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.
Sensitivity of 18F-FET PET/CT (%)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported