NCT04288518

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain
• Neoplasms

Interventions

Type	Name	Description
DRUG	SPECT or SPECT-CT with 99mTc-1-thio-D-glucose	One single intravenous injection of 99mTc-1-thio-D-glucose, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.

Timeline

• Start date: 2020-02-15
• Primary completion: 2021-02-15
• Completion: 2021-02-15
• First posted: 2020-02-28
• Last updated: 2023-10-23

Locations

1 site across 1 country: Russia