Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

Glioblastoma Clinical Trial

Official title:

Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455189
• Other study ID #: CASE1324
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Chaitra Badve, MD
• Phone: 216-844-3312
• Email: Chaitra.Badve[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 brain, better than routine MRI images.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: December 31, 2029
• Est. primary completion date: June 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Tumor
• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, UH Department of Radiology, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours post surgery
Primary	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	30 days post surgery
Primary	Feasibility as assessed by the performance of MRF/MRI infiltration mapping guidance in surgical resection of new glioblastomas	Assessed by post surgical MRI scans	Up to 72 hours post surgery
Secondary	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	6 months
Secondary	Extent of resection	As assessed by post surgical MRI scans	1 week post surgery
Secondary	Operator confidence		1 week post surgery
Secondary	Histopathological correlation		Approximately one week post surgery
Secondary	Recurrence	As assessed by MRI scans	Approximately 12 months post surgery