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NCT Number: NCT07475390

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

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.

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Key information

Conditions

Glioma (Any Grade) in the Brain Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, 634050, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

99mTc-1-thio-D-glucose

Drug

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

Other names: SPECT/CT

18F-FET

Drug

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

Other names: PET/CT

Primary outcomes

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

    Time frame: 1 hour

    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.

  2. 99mTc-1-thio-D-glucose uptake in background (SUVmean)

    Time frame: 1 hour

    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.

  3. 99mTc-1-thio-D-glucose tumor-to-background ratio (SPECT/CT)

    Time frame: 1 hour

    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).

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

    Time frame: 1 hour

    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.

  5. 18F-FET uptake in tumor (SUVmean)

    Time frame: 20 minutes

    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.

  6. 18F-FET uptake in background (SUVmean)

    Time frame: 20 minutes

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

  7. 18F-FET tumor-to-background ratio (PET/CT)

    Time frame: 20 minutes

    The PET/CT-based tumor-to-background ratio will be calculated as follows: the value of 18F-FET uptake coinciding with tumor lesions (SUVmean) will be divided by the value of 18F-FET uptake coinciding with the brain regions without pathological findings (SUVmean).

  8. Sensitivity of 18F-FET PET/CT (%)

    Time frame: 20 minutes

    Sensitivity (%) of the 18F-FET PET/CT will be assessed by comparing of cases with high 18F-FET uptake in the primary tumor with the positive for glioma results of immunohistochemical studies.

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

Molecular Imaging of Brain Tumor Using 99mTc-1-thio-D-glucose SPECT/CT and 18F-Fluoroethyl-l-tyrosine PET/CT in Primary and Recurrent Glioma Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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