Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06455189
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-weightedw and FLAIR Fluid attenuation inversion recovery images This bright peritumoral T2FLAIR 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 MRFMRI scans with targeted 5-aminolevulenic acid 5-ALA tissue sampling demonstrates an AUC of 08 for MRFMRI model for GBM infiltration prediction in peritumoral region
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-weightedw and FLAIR Fluid attenuation inversion recovery images This bright peritumoral T2FLAIR 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 MRFMRI scans with targeted 5-aminolevulenic acid 5-ALA tissue sampling demonstrates an AUC of 08 for MRFMRI model for GBM infiltration prediction in peritumoral region
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None