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

March 15, 2026 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
    • Tomsk Oblast
      • Tomsk, Tomsk Oblast, Russia, 634050
        • Tomsk National Research Medical Center of the Russian Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary and recurrent glioma patients.
Maximum (40) evaluable subjects with primary and recurrent glioma have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced
Drug: 99mTc-1-thio-D-glucose
One single injection of 99mTc-1-thio-D-glucose, followed by SPECT/CT imaging 1 hour after injection.
Other Names:
  • SPECT/CT
Drug: 18F-FET
One single injection of 18F-FET, followed by gamma camera imaging PET/CT 20 minutes after injection.
Other Names:
  • PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
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).
1 hour
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.
20 minutes
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).
20 minutes
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.
1 hour
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.
1 hour
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.
20 minutes
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.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Vladimir I Chernov, MD, Prof., Tomsk National Research Medical Center of the Russian Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99mTc-thio-glucose vs 18F-FET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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