99mTc-1-thio-D-glucose SPECT/CT Versus 18F-Fluoroethyl-l-tyrosine PET/CT in Brain Tumor Imaging

N/AActive Not RecruitingNCT07475390

Tomsk National Research Medical Center of the Russian Academy of Sciences40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Glioma (Any Grade) in the Brain

Interventions

99mTc-1-thio-D-glucoseDRUG

One single injection of 99mTc-1-thio-D-glucose, followed by SPECT/CT imaging 1 hour after injection.

18F-FETDRUG

One single injection of 18F-FET, followed by gamma camera imaging PET/CT 20 minutes after injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, Russia

Outcomes

Primary Outcomes

99mTc-1-thio-D-glucose uptake in tumor (SUVmean)

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.

Time frame: 1 hour

99mTc-1-thio-D-glucose uptake in background (SUVmean)

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.

Time frame: 1 hour

99mTc-1-thio-D-glucose tumor-to-background ratio (SPECT/CT)

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).

Time frame: 1 hour

Sensitivity of 99mTc-1-thio-D-glucose SPECT/CT (%)

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.

Time frame: 1 hour

18F-FET uptake in tumor (SUVmean)

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.

Time frame: 20 minutes

18F-FET uptake in background (SUVmean)

PET/CT-based 18F-FET uptake value in normal brain tissue will be assessed at 20 minutes after injection and measured in SUVmean.

Time frame: 20 minutes

18F-FET tumor-to-background ratio (PET/CT)

Data from ClinicalTrials.gov

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