NCT07475390

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Feb 2026May 2028

Study Start

First participant enrolled

February 15, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

March 11, 2026

Last Update Submit

June 23, 2026

Conditions

Glioma (Any Grade) in the Brain

Keywords

Glioma patients99mTc-1-thio-D-glucose SPECT/CT18F-FET PET/CT

Outcome Measures

Primary Outcomes (8)

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

    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 uptake in background (SUVmean)

    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

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

    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

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

    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 tumor (SUVmean)

    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 uptake in background (SUVmean)

    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

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

    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

  • Sensitivity of 18F-FET PET/CT (%)

    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

Study Arms (1)

Primary and recurrent glioma patients.

EXPERIMENTAL

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-glucoseDrug: 18F-FET

Interventions

99mTc-1-thio-D-glucoseDRUG

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

Also known as: SPECT/CT
Primary and recurrent glioma patients.
18F-FETDRUG

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

Also known as: PET/CT
Primary and recurrent glioma patients.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, 634050, Russia

Location

MeSH Terms

Conditions

Glioma

Interventions

(18F)fluoroethyltyrosine

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Vladimir I Chernov, MD, Prof.

    Tomsk National Research Medical Center of the Russian Academy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment Diagnostic Test: 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT for brain tumor Imaging.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)