GlioblastomaNCT02905643
Discerning Pseudoprogression vs True Tumor Growth in GBMs
An observational study of Glioblastoma, run by Ascension Health.
Trial summary
One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade 4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates and median patient survival of just 12-15… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Study subjects
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 13 Feb 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: Individuals who have or might have a brain tumor which may be a glioblastoma.
Who may be able to join
- Participants must be 18 years of age or older.
- Participants must be able to read and comprehend the English language.
- In agreement with the care providing physician, participants must be willing to have surgery to remove possible brain tumor.
- Participants must have a MRI scan within 24 hours after the tumor is removed (if a tumor is confirmed).
- Participants must have the tumor analyzed by the laboratory and pathology departments and receive the diagnosis of glioblastoma.
- Participants must be willing to follow the Stupp treatment protocol (this treatment plan and its' procedures are considered the standard for treating glioblastoma). (The Stupp protocol is the name of the radiation and chemotherapy plan that has been found to help in many cases of glioblastoma.)
- Participants must be willing to follow any additional study procedures (including having all follow-up MRIs performed at St. Vincent 86th St).
Who cannot join
- Participants are less than 18 years of age.
- Participants have had surgery for your brain tumor and NOT received the diagnosis of glioblastoma
- Participants and care providing physician have decided NOT to follow the Stupp protocol (treatment plan) for glioblastoma treatment. (Deviations or interruptions are allowed if clinically indicated)
- Participants are not having a MRI scan within 24 hours after brain tumor surgery.
- Participants are not willing to follow the study procedures.
About this study
Official title: The Use of Peak Height and Percentage Signal Recovery for Evaluation and Determination of Pseudoprogression in Glioblastoma Patients
One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade 4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates and median patient survival of just 12-15 months post-diagnosis. Treatment response is assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes which, like actual tumor progression itself, demonstrate contrast enhancement on the first post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard noninvasive tool for distinguishing between pseudoprogression and progressive disease. Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits measurement of hemodynamic imaging variables. Previous literature reports attempted to use some or all of these metrics to assess their utility in distinguishing PsP from true cancer progression. These studies showed mixed results, likely due to a number of factors, including poor statistical power, poorly defined PsP, analysis of multiple cancer grades and types, and varied analysis methodologies. The investigators aim to address these issues in this study.
Read the detailed description
See BRIEF SUMMARY section
- Conditions
- Glioblastoma
- Being tested
- Study subjects
- Keywords
- Pseudoprogression, Brain Cancer
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study subjectsOther
This study does not include an intervention it is only observational.
| Study group | Role | What they receive |
|---|---|---|
| Study subjects | Patients who have or might have a brain tumor which may be a glioblastoma. Receives: Other: Study subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging parameter utility for pseudoprogression vs. true tumor growth
The primary outcome of this study is to assess the utility of peak height, peak signal recovery, apparent diffusion coefficient, and cerebral blood volume (and their relative values) in determining, positive predictive values (PPV), negative predictive values (NPV), and likelihood ratios (LR) for identifying pseudo progression versus true tumor growth.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Why it stopped: Investigator left institution
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.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Beltz, MD, Principal investigator, Northwest Radiology Network, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905643
- Sponsor's protocol ID
- R20150109
- Status last verified
- Feb 2024
- First submitted
- 8 Sep 2016
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Peak Height and Percentage Signal Recovery for Evaluation and Determination of Pseudoprogression in Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT02905643
- Acronym / sponsor ID
- R20150109
- Conditions
- Glioblastoma
- Keywords
- Pseudoprogression, Brain Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 19 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.
One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade 4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates and median patient survival of just 12-15 months post-diagnosis. Treatment response is assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes which, like actual tumor progression itself, demonstrate contrast enhancement on the first post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard noninvasive tool for distinguishing between pseudoprogression and progressive disease. Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits measurement of hemodynamic imaging variables. Previous literature reports attempted to use some or all of these metrics to assess their utility in distinguishing PsP from true cancer progression. These studies showed mixed results, likely due to a number of factors, including poor statistical power, poorly defined PsP, analysis of multiple cancer grades and types, and varied analysis methodologies. The investigators aim to address these issues in this study.
Detailed description
See BRIEF SUMMARY section
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study subjects | – | Other: Study subjectsPatients who have or might have a brain tumor which may be a glioblastoma. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have or might have a brain tumor which may be a glioblastoma.
Key inclusion criteria (7 listed)
- Participants must be 18 years of age or older.
- Participants must be able to read and comprehend the English language.
- In agreement with the care providing physician, participants must be willing to have surgery to remove possible brain tumor.
- Participants must have a MRI scan within 24 hours after the tumor is removed (if a tumor is confirmed).
- Participants must have the tumor analyzed by the laboratory and pathology departments and receive the diagnosis of glioblastoma.
Key exclusion criteria (5 listed)
- Participants are less than 18 years of age.
- Participants have had surgery for your brain tumor and NOT received the diagnosis of glioblastoma
- Participants and care providing physician have decided NOT to follow the Stupp protocol (treatment plan) for glioblastoma treatment. (Deviations or interruptions are allowed if clinically indicated)
- Participants are not having a MRI scan within 24 hours after brain tumor surgery.
- Participants are not willing to follow the study procedures.
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 |
|---|---|---|
| Study subjectsThis study does not include an intervention it is only observational. | Other | Study subjects |
Primary outcome
Imaging parameter utility for pseudoprogression vs. true tumor growth
Time frame: Up to 24 months
The primary outcome of this study is to assess the utility of peak height, peak signal recovery, apparent diffusion coefficient, and cerebral blood volume (and their relative values) in determining, positive predictive values (PPV), negative predictive values (NPV), and likelihood ratios (LR) for identifying pseudo progression versus true tumor growth.
Results and safety
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
Eric Beltz, MD principal investigator
Northwest Radiology Network, Inc
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Ascension Health.
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 7 inclusion and 5 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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: Investigator left institution). 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?
Imaging parameter utility for pseudoprogression vs. true tumor growth (time frame: Up to 24 months). 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 22 Feb 2024.