GlioblastomaNCT02769806
Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma
An observational study of Glioblastoma and Glioblastoma Multiforme, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2016to 21 Jun 2019
- 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 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 25 patients diagnosed with GBM will be enrolled and stratified by the methylation status of their tumor; 17 MGMT-unmethylated and 8 MFMT-methylated will be enrolled.
Who may be able to join
- Histology: Glioblastoma (grade 4 astrocytoma)
- Standard-of-care, post-gd T1w image changes suggestive or consistent with of progression.
- Standard-of-care MRI included conventional DSC-PWI without unexpected technical difficulties.
- Methylation status of tumor available in medical record.
- Able to provide written informed consent.
Who cannot join
- Contraindications either to 3T MRI (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency). Screening for these contraindications will be based on history only (as it is for all routine outpatient clinical MRI at UWHC).
- Significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.
- Special subjects such as minors, mentally disabled persons, or prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression.
Read the detailed description
Investigators will compare the novel to the standard DSC-PWI methods in twenty five GBM patients to determine whether novel method improves image quality in tumor regions. We will also compare accuracy of pseudoprogression (PsP) vs. early progressive disease (ePD) determinations by the two techniques. If successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative GBM patients.
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Being tested
- MRI
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| GBM patients undergoing MRI | GBM patients undergoing standard-of-care post-operative combination chemoRT and clinically indicated MRI including standard DSC-PWI for follow-up. Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
A novel high resolution DSC-PWI imaging method
A novel high resolution DSC-PWI method will be compared to the standard DSC-PWI method to determine whether novel method improves image quality in tumor regions.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start23 May 2016
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Why it stopped: funding
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 University of Wisconsin, MadisonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Alexey Samsonov, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769806
- Sponsor's protocol ID
- UW15098
- Other IDs
- 2016-0007, A539300, SMPH\RADIOLOGY\RADIOLOGY, NCI-2019-06444, R21EB018483-01A1
- Status last verified
- Jan 2023
- First submitted
- 10 May 2016
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Currently, there is no plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma
- ClinicalTrials.gov ID
- NCT02769806
- Acronym / sponsor ID
- UW15098
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: funding
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 23 May 2016 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 12 May 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.
The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression.
Detailed description
Investigators will compare the novel to the standard DSC-PWI methods in twenty five GBM patients to determine whether novel method improves image quality in tumor regions. We will also compare accuracy of pseudoprogression (PsP) vs. early progressive disease (ePD) determinations by the two techniques. If successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative GBM patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBM patients undergoing MRI | – | Procedure: MRIGBM patients undergoing standard-of-care post-operative combination chemoRT and clinically indicated MRI including standard DSC-PWI for follow-up. |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 25 patients diagnosed with GBM will be enrolled and stratified by the methylation status of their tumor; 17 MGMT-unmethylated and 8 MFMT-methylated will be enrolled.
Key inclusion criteria (5 listed)
- Histology: Glioblastoma (grade 4 astrocytoma)
- Standard-of-care, post-gd T1w image changes suggestive or consistent with of progression.
- Standard-of-care MRI included conventional DSC-PWI without unexpected technical difficulties.
- Methylation status of tumor available in medical record.
- Able to provide written informed consent.
Key exclusion criteria (3 listed)
- Contraindications either to 3T MRI (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency). Screening for these contraindications will be based on history only (as it is for all routine outpatient clinical MRI at UWHC).
- Significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.
- Special subjects such as minors, mentally disabled persons, or prisoners.
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 |
|---|---|---|
| MRI | Procedure or surgery | GBM patients undergoing MRI |
Primary outcome
A novel high resolution DSC-PWI imaging method
Time frame: 2 years
A novel high resolution DSC-PWI method will be compared to the standard DSC-PWI method to determine whether novel method improves image quality in tumor regions.
Results and safety
The study was stopped early (reason given: funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- UW Carbone Cancer Center Home PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Currently, there is no plan to share data.
Related trials for Glioblastoma
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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.
Alexey Samsonov principal investigator
University of Wisconsin, Madison
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 Glioblastoma Multiforme, run by University of Wisconsin, Madison 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 5 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: stopped early, as of the sponsor's last update on 17 Jan 2023. 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 stopped early (reason given: funding). Results are not available in the source record.
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?
A novel high resolution DSC-PWI imaging method (time frame: 2 years). 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 17 Jan 2023.