BrainPhase 1/2NCT04288518
Molecular Imaging of Brain Tumors Using Labeled Technetium-99m 1-Thio-D-Glucose.
A Phase 1/2 study testing SPECT or SPECT-CT with 99mTc-1-thio-D-glucose in people with Brain and Neoplasms, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- SPECT or SPECT-CT with 99mTc-1-thio-D-glucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- 15 Feb 2020to 15 Feb 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is > 18 years of age
- Clinical and radiological diagnosis of a primary brain tumor or recurrence of a brain tumor with immunohistological verification.
- Clinical and radiological diagnosis of a benign intracranial lesions.
- White blood cell count: > 2.0 x 10^9/L
- Haemoglobin: > 80 g/L
- Platelets: > 50.0 x 10^9/L
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- alanine amino transferase (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
- Blood glucose level not more than 5.9 mmol/L
- A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening 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.
About this study
Official title: SPECT Imaging of Brain Tumors Using Technetium-99m Labeled 1-Thio-D-Glucose (99mTc-1-thio-D-glucose).
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:
Read more
- To assess the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of 99mTc-1-thio-D-glucose.
- 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:
- 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.
Read the 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:
- To evaluate the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors in patients with brain tumors at different time intervals.
- To evaluate dosimetry 99mTc-1-thio-D-glucose based on the pharmacokinetic parameters of the drug after a single intravenous administration.
- 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:
- 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.
- To study the diagnostic effectiveness of 99mTc-1-thio-D-glucose SPECT in imaging of brain tumors.
- 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.
- Being tested
- SPECT or SPECT-CT with 99mTc-1-thio-D-glucose
- Keywords
- 99mTc-1-thio-D-glucose, Brain, Neoplasms, SPECT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT or SPECT-CT with 99mTc-1-thio-D-glucoseDrug
Also called 99mTc-1-thio-D-glucose
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Brain Tumor | Experimental | The tested injected doses of 99mTc-1-thio-D-glucose 500 megabecquerels (MBq).
At least five (5) evaluable subjects with primary brain tumor. The tested injected dose 500 MBq. Receives: Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose |
| Recurrence of Brain Tumor | Experimental | The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq.
At least five (5) evaluable subjects with recurrence of brain tumor. The tested injected dose 500 MBq Receives: Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose |
| Benign intracranial lesions | Experimental | The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq.
At least five (5) evaluable subjects with benign intracranial lesions. The tested injected dose 500 MBq Receives: Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent)
Whole-body 99mTc-1-thio-D-glucose uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (percent) of the injected dose of the radiopharmaceutical
Measured: 24 hours
SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts)
99mTc-1-thio-D-glucose uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Measured: 6 hours
SPECT-based 99mTc-1-thio-D-glucose uptake value (counts)
Focal uptake of 99mTc-1-thio-D-glucose in the regions without pathological findings will be assessed with SPECT and measured in counts
Measured: 6 hours
Tumor-to-background ratio (unitless value)
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-1-thio-D-glucose uptake coinciding with the regions without pathological findings (counts)
Measured: 6 hours
Secondary outcomes (4)
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal physical findings (percent)
The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline)
Measured: 24 hours
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal laboratory results (percent)
The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)
Measured: 24 hours
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of adverse events (percent)
The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of adverse events (percent)
Measured: 24 hours
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the need for concomitant medication (percent)
The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of administration of concomitant medication (percent)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start15 Feb 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Sponsor
- Investigators
- Vladimr I Chernov, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288518
- Sponsor's protocol ID
- ORI-07
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2020
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
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
- SPECT Imaging of Brain Tumors Using Technetium-99m Labeled 1-Thio-D-Glucose (99mTc-1-thio-D-glucose).
- ClinicalTrials.gov ID
- NCT04288518
- Acronym / sponsor ID
- ORI-07
- Keywords
- 99mTc-1-thio-D-glucose, Brain, Neoplasms, SPECT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 28 Feb 2020 (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.
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:
- To assess the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of 99mTc-1-thio-D-glucose.
- 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:
- 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:
- To evaluate the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors in patients with brain tumors at different time intervals.
- To evaluate dosimetry 99mTc-1-thio-D-glucose based on the pharmacokinetic parameters of the drug after a single intravenous administration.
- 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:
- 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.
- To study the diagnostic effectiveness of 99mTc-1-thio-D-glucose SPECT in imaging of brain tumors.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Brain Tumor | Experimental | Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucoseThe tested injected doses of 99mTc-1-thio-D-glucose 500 megabecquerels (MBq). At least five (5) evaluable subjects with primary brain tumor. The tested injected dose 500 MBq. |
| Recurrence of Brain Tumor | Experimental | Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucoseThe tested injected doses of 99mTc-1-thio-D-glucose 500 MBq. At least five (5) evaluable subjects with recurrence of brain tumor. The tested injected dose 500 MBq |
| Benign intracranial lesions | Experimental | Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucoseThe tested injected doses of 99mTc-1-thio-D-glucose 500 MBq. At least five (5) evaluable subjects with benign intracranial lesions. The tested injected dose 500 MBq |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is > 18 years of age
- Clinical and radiological diagnosis of a primary brain tumor or recurrence of a brain tumor with immunohistological verification.
- Clinical and radiological diagnosis of a benign intracranial lesions.
- White blood cell count: > 2.0 x 10^9/L
- Haemoglobin: > 80 g/L
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 |
|---|---|---|
| SPECT or SPECT-CT with 99mTc-1-thio-D-glucoseAlso: 99mTc-1-thio-D-glucoseOne single intravenous injection of 99mTc-1-thio-D-glucose, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours. | Drug | Benign intracranial lesions, Primary Brain Tumor, Recurrence of Brain Tumor |
Primary outcome
Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent)
Time frame: 24 hours
Whole-body 99mTc-1-thio-D-glucose uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (percent) of the injected dose of the radiopharmaceutical
SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts)
Time frame: 6 hours
99mTc-1-thio-D-glucose uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based 99mTc-1-thio-D-glucose uptake value (counts)
Time frame: 6 hours
Focal uptake of 99mTc-1-thio-D-glucose in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (unitless value)
Time frame: 6 hours
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-1-thio-D-glucose uptake coinciding with the regions without pathological findings (counts)
4 secondary outcomes
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal physical findings (percent)
Time frame: 24 hours
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal laboratory results (percent)
Time frame: 24 hours
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of adverse events (percent)
Time frame: 24 hours
Safety attributable to 99mTc-1-thio-D-glucose injections, based on the need for concomitant medication (percent)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
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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.
Vladimr I Chernov principal investigator
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SPECT or SPECT-CT with 99mTc-1-thio-D-glucose in people with Brain and Neoplasms, 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 13 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: finished, 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent) (time frame: 24 hours). The study lists 4 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.