GlioblastomaPhase 1NCT06455189
Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
A Phase 1 study testing MRF/MRI infiltration guidance for extended resection in people with Glioblastoma and Brain Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glioblastoma, Brain Tumor
- What is being tested?
- MRF/MRI infiltration guidance for extended resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to 31 Dec 2029
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- MR imaging findings suggestive of GB
- Maximal tumor diameter greater than 3 cm
- Ability to provide written informed consent
- Ability to undergo MRI scan
- Consideration for biopsy, subtotal or gross total resection.
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- Age > 18
- MR imaging findings suggestive of GB
- Maximal tumor diameter greater than 3 cm
- Ability to provide written informed consent
- Ability to undergo MRI scan
- Lesions amenable to gross total resection
- Presence of peritumoral FLAIR signal abnormality beyond the area of enhancement.
Who cannot join
- Contraindications to MRI
- Contraindication to surgical treatment
- Prior treatment for glioblastoma
- Stage II:
- Inability to undergo MRI imaging
- Participants undergoing only stereotactic biopsy or less than gross total resection
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- Participants undergoing LITT
- Inability to consent for the study
- Previously treated/ recurrent glioma.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, UH Department of Radiology, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the brain, better than routine MRI images.
Read the detailed description
Glioblastomas (GBs) are aggressive malignant brain tumors with a median survival of less than 15 months . Infiltration of cancer beyond the tumor margins causes recurrence in nearly 100% of GBs; however, this cannot be measured by current imaging techniques . Availability of reliable and reproducible infiltration prediction maps at initial diagnosis will open new treatment opportunities such as targeted surgery or escalated radiation therapy (RT).
On clinical contrast enhanced (CE) magnetic resonance imaging (MRI) scans, a typical GB demonstrates an enhancing mass with central necrosis and an extensive surrounding, peritumoral region with bright signal on T2-weighted(w) and FLAIR (Fluid attenuation inversion recovery) images. This bright, peritumoral T2/FLAIR region is known to contain vasogenic edema and tumor infiltration, as it is well known that GBs infiltrate beyond the enhancing tumor margins.
Since there is a clear link between extent of tumor resection and survival the challenge for neurosurgeons is maximizing resection of tumor, while avoiding neurological injury. Typically, the central region of the tumor can be safely resected with minimal risk. The challenge lies in maximal safe resection along the tumor margins as it infiltrates normal brain. MR Fingerprinting is a quantitative imaging (QI) scan developed at CWRU that provides rapid quantification of multiple tissue properties, such as T1 and T2 relaxation maps, with high reproducibility and excellent tissue characterization. Our preliminary analysis of retrospective data of 60 GB participants with MRF+MRI scans with targeted 5-aminolevulenic acid (5-ALA) tissue sampling demonstrates an AUC of 0.8 for MRF/MRI model for GBM infiltration prediction in peritumoral region .
- Conditions
- Glioblastoma, Brain Tumor
- Being tested
- Control Group - Standard of care neurosurgical resection, MRF/MRI infiltration guidance for extended resection
- Keywords
- Radiation Therapy, Magnetic Resonance Fingerprinting, MRI
- 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.
Control Group - Standard of care neurosurgical resectionOther
The control group will include only standard of care tools. - Standard of care neurosurgical resection will include the use of all standard neurosurgical instruments and techniques (eg, microscope, intraoperative ultrasound, 5-ALA fluorescence guided surgery and neuronavigation system).
MRF/MRI infiltration guidance for extended resectionProcedure or surgery
Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Routine standard of care process will be followed for neurosurgical guidance Receives: Other: Control Group - Standard of care neurosurgical resection |
| Group 2 | Experimental | The surgeon will have access to advanced MRI and MRF analysis research images during surgery and may use them for guidance, in addition to all routinely used surgical tools. Receives: Procedure: MRF/MRI infiltration guidance for extended resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experienced serious adverse events(SAEs) at 48 hours post targeted biopsy sampling procedure
Safety is defined as the absence of significant complications at 48 hours. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm
Measured: 48 hours post surgery
Number of participants who experienced serious adverse events(SAEs) at 30 days post targeted biopsy sampling procedure
Safety is defined as the absence of significant complications at 30 days. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm
Measured: 30 days post surgery
Feasibility as assessed by the performance of MRF/MRI infiltration mapping guidance in surgical resection of new glioblastomas
Assessed by post surgical MRI scans
Measured: Up to 72 hours post surgery
Secondary outcomes (5)
Progression Free Survival(PFS)
PFS will be estimated using Kaplan-Meier method and the difference of PFS between two arms will be compared using log-rank test
Measured: 6 months
Extent of resection
As assessed by post surgical MRI scans
Measured: 1 week post surgery
Operator confidence
Measured: 1 week post surgery
Histopathological correlation
Measured: Approximately one week post surgery
Recurrence
As assessed by MRI scans
Measured: Approximately 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study startDec 2025 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Why it stopped: Terminated IRB
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 Case 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated in a one-to-one ratio to undergo either tumor resection with intraoperative MRF/MRI infiltration mapping guidance or with standard of care neurosurgical techniques. The investigators who assess eligibility of participants and schedule surgeries (neurosurgeons, residents, research nurse) will be masked to treatment group assignment by use of a sealed-envelope design. The treatment group assignments will be disclosed after surgery is scheduled and after written consent is obtained, usually on the day before the operation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chaitra Badve, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterTiffany Hodges, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455189
- Sponsor's protocol ID
- CASE1324
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
- ClinicalTrials.gov ID
- NCT06455189
- Acronym / sponsor ID
- CASE1324
- Conditions
- Glioblastoma, Brain Tumor
- Keywords
- Radiation Therapy, Magnetic Resonance Fingerprinting, MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jun 2024 (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.
Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the brain, better than routine MRI images.
Detailed description
Glioblastomas (GBs) are aggressive malignant brain tumors with a median survival of less than 15 months . Infiltration of cancer beyond the tumor margins causes recurrence in nearly 100% of GBs; however, this cannot be measured by current imaging techniques . Availability of reliable and reproducible infiltration prediction maps at initial diagnosis will open new treatment opportunities such as targeted surgery or escalated radiation therapy (RT).
On clinical contrast enhanced (CE) magnetic resonance imaging (MRI) scans, a typical GB demonstrates an enhancing mass with central necrosis and an extensive surrounding, peritumoral region with bright signal on T2-weighted(w) and FLAIR (Fluid attenuation inversion recovery) images. This bright, peritumoral T2/FLAIR region is known to contain vasogenic edema and tumor infiltration, as it is well known that GBs infiltrate beyond the enhancing tumor margins.
Since there is a clear link between extent of tumor resection and survival the challenge for neurosurgeons is maximizing resection of tumor, while avoiding neurological injury. Typically, the central region of the tumor can be safely resected with minimal risk. The challenge lies in maximal safe resection along the tumor margins as it infiltrates normal brain. MR Fingerprinting is a quantitative imaging (QI) scan developed at CWRU that provides rapid quantification of multiple tissue properties, such as T1 and T2 relaxation maps, with high reproducibility and excellent tissue characterization. Our preliminary analysis of retrospective data of 60 GB participants with MRF+MRI scans with targeted 5-aminolevulenic acid (5-ALA) tissue sampling demonstrates an AUC of 0.8 for MRF/MRI model for GBM infiltration prediction in peritumoral region .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a one-to-one ratio to undergo either tumor resection with intraoperative MRF/MRI infiltration mapping guidance or with standard of care neurosurgical techniques. The investigators who assess eligibility of participants and schedule surgeries (neurosurgeons, residents, research nurse) will be masked to treatment group assignment by use of a sealed-envelope design. The treatment group assignments will be disclosed after surgery is scheduled and after written consent is obtained, usually on the day before the operation.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Control Group - Standard of care neurosurgical resectionRoutine standard of care process will be followed for neurosurgical guidance |
| Group 2 | Experimental | Procedure: MRF/MRI infiltration guidance for extended resectionThe surgeon will have access to advanced MRI and MRF analysis research images during surgery and may use them for guidance, in addition to all routinely used surgical tools. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age > 18
- MR imaging findings suggestive of GB
- Maximal tumor diameter greater than 3 cm
- Ability to provide written informed consent
- Ability to undergo MRI scan
Key exclusion criteria (9 listed)
- Contraindications to MRI
- Contraindication to surgical treatment
- Prior treatment for glioblastoma
- Inability to undergo MRI imaging
- Participants undergoing only stereotactic biopsy or less than gross total resection
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 |
|---|---|---|
| Control Group - Standard of care neurosurgical resectionThe control group will include only standard of care tools. - Standard of care neurosurgical resection will include the use of all standard neurosurgical instruments and techniques (eg, microscope, intraoperative ultrasound, 5-ALA fluorescence guided surgery and neuronavigation system). | Other | Group 1 |
| MRF/MRI infiltration guidance for extended resectionMagnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body | Procedure or surgery | Group 2 |
Primary outcome
Number of participants who experienced serious adverse events(SAEs) at 48 hours post targeted biopsy sampling procedure
Time frame: 48 hours post surgery
Safety is defined as the absence of significant complications at 48 hours. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm
Number of participants who experienced serious adverse events(SAEs) at 30 days post targeted biopsy sampling procedure
Time frame: 30 days post surgery
Safety is defined as the absence of significant complications at 30 days. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm
Feasibility as assessed by the performance of MRF/MRI infiltration mapping guidance in surgical resection of new glioblastomas
Time frame: Up to 72 hours post surgery
Assessed by post surgical MRI scans
5 secondary outcomes
Progression Free Survival(PFS)
Time frame: 6 months
Extent of resection
Time frame: 1 week post surgery
Operator confidence
Time frame: 1 week post surgery
Histopathological correlation
Time frame: Approximately one week post surgery
Recurrence
Time frame: Approximately 12 months post surgery
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 1 Jul 2026.
- 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.
Chaitra Badve, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Tiffany Hodges, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRF/MRI infiltration guidance for extended resection in people with Glioblastoma and Brain Tumor, run by Case 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 13 inclusion and 9 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 1 Jul 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 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.
What does this 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.
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 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?
Number of participants who experienced serious adverse events(SAEs) at 48 hours post targeted biopsy sampling procedure (time frame: 48 hours post surgery). The study lists 3 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 1 Jul 2026.