Clinical trial NCT06455189: Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
Official title: Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Glioblastoma
Brain Tumor
Keywords: Radiation Therapy
Magnetic Resonance Fingerprinting
MRI
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 114
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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 .

Eligibility 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.

Primary outcomes:
measure: Number of participants who experienced serious adverse events(SAEs) at 48 hours post targeted biopsy sampling procedure
timeFrame: 48 hours post surgery
measure: Number of participants who experienced serious adverse events(SAEs) at 30 days post targeted biopsy sampling procedure
timeFrame: 30 days post surgery
measure: Feasibility as assessed by the performance of MRF/MRI infiltration mapping guidance in surgical resection of new glioblastomas
timeFrame: Up to 72 hours post surgery
Secondary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 6 months
measure: Extent of resection
timeFrame: 1 week post surgery
measure: Operator confidence
timeFrame: 1 week post surgery
measure: Histopathological correlation
timeFrame: Approximately one week post surgery
measure: Recurrence
timeFrame: Approximately 12 months post surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, UH Department of Radiology, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Chaitra Badve, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Tiffany Hodges, MD
role: PRINCIPAL_INVESTIGATOR
References: