Molecular Imaging of Brain Tumors Using Labeled Technetium-99m 1-Thio-D-Glucose.
Condition: Brain; Neoplasms
MeSH terms: Neoplasms; Brain Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): SPECT or SPECT-CT with 99mTc-1-thio-D-glucose
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): 99mTc-1-thio-D-glucose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 99mTc-1-thio-D-glucose; Brain; Neoplasms; SPECT