Spots Global Cancer Trial Database for Molecular Imaging of Brain Tumors Using Labeled Technetium-99m 1-Thio-D-Glucose.

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Trial Identification

Brief Title: Molecular Imaging of Brain Tumors Using Labeled Technetium-99m 1-Thio-D-Glucose.

Official Title: SPECT Imaging of Brain Tumors Using Technetium-99m Labeled 1-Thio-D-Glucose (99mTc-1-thio-D-glucose).

Study ID: NCT04288518

Conditions

Brain

Neoplasms

Interventions

SPECT or SPECT-CT with 99mTc-1-thio-D-glucose

Study Description

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.