GlioblastomaNCT02919332
Delayed 18F-FDG PET/CT in Improving Visualization of Brain Tumors in Patients With Glioblastoma
An observational study of Glioblastoma and Glioma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in patients with glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioblastoma, Glioma
- What is being tested?
- Computed Tomography, Fludeoxyglucose F-18 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2016to 12 Dec 2018
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years of age who have been diagnosed with a brain tumor and are undergoing a PET/CT scan..
Who may be able to join
- Patients with histologically proven high grade glioma scheduled for 18F-FDG PET/CT
Who cannot join
- Severe psychiatric illness
- Inability to give written consent
- Breast feeding/pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Improved Visualization of Glioblastoma Using Delayed 18F-FDG PET/CT.
This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG administration and PET/CT scan may improve the visualization of brain tumors in patients with glioblastoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To improve the visualization/delineation of glioblastoma lesions using delayed 18F-FDG PET/CT imaging.
OUTLINE:
Patients receive fludeoxyglucose F-18 intravenously (IV). Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection.
Note:
Standard Uptake Value (SUV) is defined for state-of-the art PET/CT scanners as Standardized uptake values = count activity per ml within region of interest (MBq/ml)/[injected dose (MBq)/body weight (kgx1000)]
- Conditions
- Glioblastoma, Glioma
- Being tested
- Computed Tomography, Fludeoxyglucose F-18, Positron Emission Tomography
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo 18F-FDG PET/CT
Fludeoxyglucose F-18Radiation
Also called 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan
Undergo 18F-FDG PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (18F-FDG PET/CT) | Patients receive fludeoxyglucose F-18 IV. Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection. Receives: Procedure: Computed Tomography; Radiation: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor-to-background ratio on delayed scans (240 min after injection)
Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)
Measured: Baseline up to 240 minutes after injection
Tumor-to-background ratio on standard scans (60 min after injection)
Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)
Measured: Baseline up to 60 minutes after injection
Secondary outcomes (2)
Standard uptake value comparison
Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on delayed scans (240 min after injection)
Measured: 240 minutes post injection
Standard uptake value comparison
Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on standard scans (60 min after injection)
Measured: 60 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start8 Jun 2016
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Why it stopped: No participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Czernin, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919332
- Sponsor's protocol ID
- 16-000600
- Other IDs
- NCI-2016-01214, JCCCID655, 16-000600
- Status last verified
- Feb 2019
- First submitted
- 30 Aug 2016
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Visualization of Glioblastoma Using Delayed 18F-FDG PET/CT.
- ClinicalTrials.gov ID
- NCT02919332
- Acronym / sponsor ID
- 16-000600
- Conditions
- Glioblastoma, Glioma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- 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.
This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG administration and PET/CT scan may improve the visualization of brain tumors in patients with glioblastoma.
Detailed description
PRIMARY OBJECTIVES:
- To improve the visualization/delineation of glioblastoma lesions using delayed 18F-FDG PET/CT imaging.
OUTLINE:
Patients receive fludeoxyglucose F-18 intravenously (IV). Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection.
Note:
Standard Uptake Value (SUV) is defined for state-of-the art PET/CT scanners as Standardized uptake values = count activity per ml within region of interest (MBq/ml)/[injected dose (MBq)/body weight (kgx1000)]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (18F-FDG PET/CT) | – | Procedure: Computed Tomography, Radiation: Fludeoxyglucose F-18, Procedure: Positron Emission TomographyPatients receive fludeoxyglucose F-18 IV. Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age who have been diagnosed with a brain tumor and are undergoing a PET/CT scan..
Key inclusion criteria (1 listed)
- Patients with histologically proven high grade glioma scheduled for 18F-FDG PET/CT
Key exclusion criteria (3 listed)
- Severe psychiatric illness
- Inability to give written consent
- Breast feeding/pregnancy
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo 18F-FDG PET/CT | Procedure or surgery | Diagnostic (18F-FDG PET/CT) |
| Fludeoxyglucose F-18Also: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18Given IV | Radiation | Diagnostic (18F-FDG PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography ScanUndergo 18F-FDG PET/CT | Procedure or surgery | Diagnostic (18F-FDG PET/CT) |
Primary outcome
Tumor-to-background ratio on delayed scans (240 min after injection)
Time frame: Baseline up to 240 minutes after injection
Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)
Tumor-to-background ratio on standard scans (60 min after injection)
Time frame: Baseline up to 60 minutes after injection
Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)
2 secondary outcomes
Standard uptake value comparison
Time frame: 240 minutes post injection
Standard uptake value comparison
Time frame: 60 minutes post injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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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.
Johannes Czernin principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Glioma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Jul 2020. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Tumor-to-background ratio on delayed scans (240 min after injection) (time frame: Baseline up to 240 minutes after injection). The study lists 2 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 Jul 2020.