Molecular Imaging of Brain Tumors Using Labeled Technetium-99m 1-Thio-D-Glucose.
- Conditions
- BrainNeoplasms
- Interventions
- Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose
- Registration Number
- NCT04288518
- Brief Summary
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.
- Detailed Description
The overall goal is to study the effectiveness of SPECT imaging of primary brain tumors and relapse of brain tumors using technetium-99m labeled glucose.
Phase I of the study:
Biodistribution of 99mTc-1-thio-D-glucose in patients with primary brain tumors and in patients with recurrence of a brain tumor.
The main objectives of the study:
1. To evaluate the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors in patients with brain tumors at different time intervals.
2. To evaluate dosimetry 99mTc-1-thio-D-glucose 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-1-thio-D-glucose after a single intravenous administration in a diagnostic dosage.
Additional research tasks:
1. To conduct a comparative analysis of the diagnostic information obtained in the visualization of brain tumors by SPECT using 99mTc-1-thio-D-glucose with data obtained by magnetic resonance imaging (MRI) and/or positron emission tomography (PET) and immunohistochemical (IHC) research of postoperative material.
2. To study the diagnostic effectiveness of 99mTc-1-thio-D-glucose SPECT in imaging of brain tumors.
3. To evaluate the overall survival of patients with brain tumors depending on the results of 99mTc-1-thio-D-glucose SPECT.
Methodology:
Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary Brain Tumor SPECT or SPECT-CT with 99mTc-1-thio-D-glucose The tested injected doses of 99mTc-1-thio-D-glucose 500 megabecquerels (MBq). At least five (5) evaluable subjects with primary brain tumor. The tested injected dose 500 MBq. Benign intracranial lesions SPECT or SPECT-CT with 99mTc-1-thio-D-glucose The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq. At least five (5) evaluable subjects with benign intracranial lesions. The tested injected dose 500 MBq Recurrence of Brain Tumor SPECT or SPECT-CT with 99mTc-1-thio-D-glucose The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq. At least five (5) evaluable subjects with recurrence of brain tumor. The tested injected dose 500 MBq
- Primary Outcome Measures
Name Time Method SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts) 6 hours 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent) 24 hours 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
SPECT-based 99mTc-1-thio-D-glucose uptake value (counts) 6 hours Focal uptake of 99mTc-1-thio-D-glucose in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (unitless value) 6 hours 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)
- Secondary Outcome Measures
Name Time Method Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal laboratory results (percent) 24 hours 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)
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal physical findings (percent) 24 hours 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)
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of adverse events (percent) 24 hours The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of adverse events (percent)
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the need for concomitant medication (percent) 24 hours The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of administration of concomitant medication (percent)
Trial Locations
- Locations (1)
TomskNRMC
🇷🇺Tomsk, Russian Federation