Glioblastoma MultiformeNCT03401866
Multi-site Validation and Application of a Consensus DSC-MRI Protocol
A study testing DSC-MRI in people with Glioblastoma Multiforme and Gliosarcoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 3 sites in United States.
Trial summary
This clinical trial is to validate and demonstrate the clinical usefulness of a protocol for Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Gliosarcoma
- What is being tested?
- DSC-MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2018to Jul 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
- Patient is currently being treated with standard first-line therapy for glioblastoma/gliosarcoma
- Karnofsky performance status ≥ 70
- Age ≥ 18 years
- Women must not be pregnant or breast-feeding as gadolinium enhanced MRI is contra-indicated
- Progressive contrast enhancement (> 25% increase in contrast enhancing volume compared to nadir, not corresponding to a region of peri-operative infarct seen on immediate post-op MRI) identified on routine surveillance MRI, with plan for surgical biopsy/resection. Measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm and at least 10 mm in the 3rd orthogonal direction. This must be the patient's initial recurrence.
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- Intratumoral hemorrhage (acute, subacute, or chronic) as seen on hemosiderin-sensitive (gradient-echo) MRI may preclude patient inclusion because of anticipated limited evaluation due to magnetic susceptibility artifact on the heavily T2*-weighted DSC-MRI images. If the region of enhancing tumor not affected by blooming artifact on the hemosiderin-sensitive images does not meet the 10 x 10 x 10 mm "measurable enhancement" threshold specified elsewhere, the patient is ineligible.
- Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
- No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR);
- Weight compatible with limits imposed by the MRI scanner table.
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kathleen Schmainda, PhD
Brown University
Providence, Rhode Island, 02912
Mayo Clinic
Scottsdale, Arizona, 85054
Leland Hu, MD
About this study
Official title: Multi-site Validation and Application of a Consensus Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Protocol
This clinical trial is to validate and demonstrate the clinical usefulness of a protocol for Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors.
Read the detailed description
Although DSC-MRI itself is not novel, the consensus protocol tested herein is newly developed in response to a stated need by federal agencies (FDA, NCI) for standardization of imaging endpoints, including perfusion-weighted MRI, in multi-center clinical trials of GBM therapies. Through use of stereotactic methodologies that have been used to demonstrate that rCBV(relative cerebral blood flow) and FTB(fractional tumor burden) measures made by the consensus DSC-MRI protocol are concordant with tissue histology, this multi-site trial will be the first to validate a consensus DSC-MRI protocol on multiple platforms representing all major MRI scanner manufacturers. The trial also formally compares two contrast agent dosing schemes proposed in the consensus protocol, a single-dose BTIP-compliant scheme and a double-dose scheme. Such a comparison has never been tested in patients before, and addresses a longstanding controversy regarding contrast agent administration and dosing for DSC-MRI. Successful validation of the consensus DSC-MRI protocol will likely shift clinical practice paradigms. To date, the widespread adoption of DSC-MRI has been limited by inconsistent published methodologies, rCBV thresholds, and impact on clinical decision making. This trial seeks to improve confidence in DSCMRI methodology as it will foster its adoption for multicenter trials, facilitating the development and testing of novel therapeutic agents and treatment strategies for GBM, and shift clinical practice paradigms by providing strong evidence to support the inclusion of DSC-MRI in established response assessment criteria (i.e., modified RANO).
- Conditions
- Glioblastoma Multiforme, Gliosarcoma
- Being tested
- DSC-MRI
- Keywords
- brain tumor
- Medical subject headings
- Glioblastoma, Gliosarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSC-MRIDiagnostic test
The multiple dose protocol with sequential DSC-MRI scans enables comparison of BTIP compliant and double-dose injections schemes."
| Study group | Role | What they receive |
|---|---|---|
| DSC-MRI scan | Other | All subjects will receive a double dose injection protocol that will be split into multiple doses for sequential DSC-MRI scans. Receives: Diagnostic Test: DSC-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic measures of tumor fraction
Apply fractional tumor burden (FTB) rCBV thresholding methods to quantify recurrent tumor burden and compare this against histopathologic tumor burden from corresponding surgical specimens.
Measured: 1 day
Secondary outcomes (2)
Determine the repeatability of rCBV measured with the consensus DSC-MRI protocol.
"The repeatability of rCBV measured with the consensus DSC-MRI protocol will be quantified using the intra-class correlation coefficient (ICC).
Measured: 1 week
Determine overall survival (OS) in recurrent GBM patients.
follow up for up to 3 years post enrollment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study startFeb 2018 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Quarles, PhD, Principal investigator, Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401866
- Sponsor's protocol ID
- 17-DSC-MRI-Quarles
- Status last verified
- Jan 2018
- First submitted
- 11 Dec 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Validation and Application of a Consensus Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Protocol
- ClinicalTrials.gov ID
- NCT03401866
- Acronym / sponsor ID
- 17-DSC-MRI-Quarles
- Conditions
- Glioblastoma Multiforme, Gliosarcoma
- Keywords
- brain tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 17 Jan 2018 (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.
This clinical trial is to validate and demonstrate the clinical usefulness of a protocol for Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors.
Detailed description
Although DSC-MRI itself is not novel, the consensus protocol tested herein is newly developed in response to a stated need by federal agencies (FDA, NCI) for standardization of imaging endpoints, including perfusion-weighted MRI, in multi-center clinical trials of GBM therapies. Through use of stereotactic methodologies that have been used to demonstrate that rCBV(relative cerebral blood flow) and FTB(fractional tumor burden) measures made by the consensus DSC-MRI protocol are concordant with tissue histology, this multi-site trial will be the first to validate a consensus DSC-MRI protocol on multiple platforms representing all major MRI scanner manufacturers. The trial also formally compares two contrast agent dosing schemes proposed in the consensus protocol, a single-dose BTIP-compliant scheme and a double-dose scheme. Such a comparison has never been tested in patients before, and addresses a longstanding controversy regarding contrast agent administration and dosing for DSC-MRI. Successful validation of the consensus DSC-MRI protocol will likely shift clinical practice paradigms. To date, the widespread adoption of DSC-MRI has been limited by inconsistent published methodologies, rCBV thresholds, and impact on clinical decision making. This trial seeks to improve confidence in DSCMRI methodology as it will foster its adoption for multicenter trials, facilitating the development and testing of novel therapeutic agents and treatment strategies for GBM, and shift clinical practice paradigms by providing strong evidence to support the inclusion of DSC-MRI in established response assessment criteria (i.e., modified RANO).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSC-MRI scan | Other | Diagnostic Test: DSC-MRIAll subjects will receive a double dose injection protocol that will be split into multiple doses for sequential DSC-MRI scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
- Patient is currently being treated with standard first-line therapy for glioblastoma/gliosarcoma
- Karnofsky performance status ≥ 70
- Age ≥ 18 years
- Women must not be pregnant or breast-feeding as gadolinium enhanced MRI is contra-indicated
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| DSC-MRIThe multiple dose protocol with sequential DSC-MRI scans enables comparison of BTIP compliant and double-dose injections schemes." | Diagnostic test | DSC-MRI scan |
Primary outcome
Histologic measures of tumor fraction
Time frame: 1 day
Apply fractional tumor burden (FTB) rCBV thresholding methods to quantify recurrent tumor burden and compare this against histopathologic tumor burden from corresponding surgical specimens.
2 secondary outcomes
Determine the repeatability of rCBV measured with the consensus DSC-MRI protocol.
Time frame: 1 week
Determine overall survival (OS) in recurrent GBM patients.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- 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.
Chad Quarles, PhD principal investigator
Barrow Neurological Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSC-MRI in people with Glioblastoma Multiforme and Gliosarcoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 3 sites 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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chad Quarles, PhD (602-406-3484, Chad.Quarles@barrowneuro.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic measures of tumor fraction (time frame: 1 day). 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 2018.