Glioma (Any Grade) in the BrainNCT07475390
99mTc-1-thio-D-glucose SPECT/CT Versus 18F-Fluoroethyl-l-tyrosine PET/CT in Brain Tumor Imaging
A study testing 99mTc-1-thio-D-glucose and 18F-FET in people with Glioma (Any Grade) in the Brain, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma (Any Grade) in the Brain
- What is being tested?
- 99mTc-1-thio-D-glucose and 18F-FET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 15 Feb 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, Tomsk Oblast, 634050
About this study
Official 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
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.
Read the 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.
- Conditions
- Glioma (Any Grade) in the Brain
- Being tested
- 99mTc-1-thio-D-glucose, 18F-FET
- Keywords
- Glioma patients, 99mTc-1-thio-D-glucose SPECT/CT, 18F-FET PET/CT
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-1-thio-D-glucoseDrug
Also called SPECT/CT
One single injection of 99mTc-1-thio-D-glucose, followed by SPECT/CT imaging 1 hour after injection.
18F-FETDrug
Also called PET/CT
One single injection of 18F-FET, followed by gamma camera imaging PET/CT 20 minutes after injection.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 99mTc-1-thio-D-glucose; Drug: 18F-FET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma (Any Grade) in the BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Diagnostic Test: 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT for brain tumor Imaging.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir I Chernov, MD, Prof., Principal investigator, Tomsk National Research Medical Center of the Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475390
- Sponsor's protocol ID
- ORI-16
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07475390
- Acronym / sponsor ID
- ORI-16
- Conditions
- Glioma (Any Grade) in the Brain
- Keywords
- Glioma patients, 99mTc-1-thio-D-glucose SPECT/CT, 18F-FET PET/CT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Diagnostic Test: 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT for brain tumor Imaging.
| Arm | Type | Receives |
|---|---|---|
| Primary and recurrent glioma patients. | Experimental | Drug: 99mTc-1-thio-D-glucose, Drug: 18F-FETMaximum (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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-1-thio-D-glucoseAlso: SPECT/CTOne single injection of 99mTc-1-thio-D-glucose, followed by SPECT/CT imaging 1 hour after injection. | Drug | Primary and recurrent glioma patients. |
| 18F-FETAlso: PET/CTOne single injection of 18F-FET, followed by gamma camera imaging PET/CT 20 minutes after injection. | Drug | Primary and recurrent glioma patients. |
Primary outcome
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.
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.
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).
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.
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.
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir I Chernov, MD, Prof. principal investigator
Tomsk National Research Medical Center of the Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-1-thio-D-glucose and 18F-FET in people with Glioma (Any Grade) in the Brain, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
99mTc-1-thio-D-glucose uptake in tumor (SUVmean) (time frame: 1 hour). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.