Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101069
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-10-20
Brief Title:
Development of MRF for Characterization of Brain Tumors After Radiotherapy
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging MRI technique named Magnetic Resonance Fingerprinting or MRF to achieve high-quality images within a short scan time of 5 min for viewing the entire brain This is an advanced quantitative assessment of brain tissues This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis individuals with recurrent tumors and healthy individuals who have no brain diseases and have not had radiation treatment to the brain Participants will undergo an MRI scan at a one-time research study visit no extra tests or procedures will be required for this research study
The primary objectives of this study are
To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage
To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis
The primary objectives of this study are
To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage
To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis
Detailed Description:
Although Stereotactic radiosurgery SRS is utilized as an effective treatment method after several months to over 1 year following SRS 33 of treated brain metastases increase in size on imaging which is suspicious for tumor progression However based on findings in follow-up biopsies the majority of newly detected metastases on imaging are radiation treatment effects instead of active tumor So far the only gold standard to differentiate active tumor and radiation necrosis is surgical resection for pathologic confirmation which is invasive not favored for poor surgical candidates and should be avoided in cases of necrosis The existing clinical imaging techniques have poor sensitivity or specificity in differentiating these two types of tissues Recently a novel MRI data acquisition approach namely MR Fingerprinting MRF has been introduced for the simultaneous measurement of multiple important parameters in a single MRI scan In addition quantitative diffusion MRI such as the intravoxel incoherent motion IVIM technique can provide a noninvasive and powerful tool to quantify microstructural information by measuring water diffusion and microcirculation perfusion in vivo This study aims to demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage It also aims to apply the developed quantitative approach in combination with IVIM MRI for the differentiation of tumor recurrence and radiation necrosis The multi-parametric quantitative measures developed in this study could establish a new fundamental biomarker for the diagnosis and monitoring of brain tumors
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?:
None
Is an FDA AA801 Violation?:
None