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Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Stage I:

Inclusion criteria:

  • - 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.

Exclusion Criteria:

  • - Contraindications to MRI.
  • - Contraindication to surgical treatment.
  • - Prior treatment for glioblastoma.
Stage II:

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - Inability to undergo MRI imaging.
  • - Participants undergoing only stereotactic biopsy or less than gross total resection.
  • - Participants undergoing LITT.
  • - Inability to consent for the study.
  • - Previously treated/ recurrent glioma.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06455189
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Case Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Chaitra Badve, MDTiffany Hodges, MD
Principal Investigator Affiliation University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Brain Tumor
Additional Details

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 .

Arms & Interventions

Arms

Other: Group 1

Routine standard of care process will be followed for neurosurgical guidance

Experimental: Group 2

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.

Interventions

Other: - Control Group - Standard of care neurosurgical resection

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).

Procedure: - MRF/MRI infiltration guidance for extended resection

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Address

University Hospitals Cleveland Medical Center, UH Department of Radiology, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106

Site Contact

Chaitra Badve, MD

[email protected]

216-844-3312

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