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Procedure
MRF + IVIM MRI for Brain Cancer
N/A
Recruiting
Led By Samuel Chao, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy-proven cases of developed recurrent tumor or radiation necrosis
ECOG performance status 0-2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the total 30-45 minute scan time
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help differentiate between brain tumors and radiation necrosis with MRI scan in just 5 minutes.
Who is the study for?
This trial is for individuals who have had radiation therapy and are diagnosed with either recurrent brain tumors or radiation necrosis. It's also open to healthy people without brain diseases. Participants should not have a history of stroke, cognitive impairments, be able to consent, and have a life expectancy over 6 months.
What is being tested?
The study tests an MRI technique called Magnetic Resonance Fingerprinting (MRF) combined with IVIM MRI without contrast. The goal is to get high-quality images quickly to distinguish between brains affected by tumor recurrence and those with tissue death due to radiation.
What are the potential side effects?
Since the intervention involves only non-invasive imaging techniques like MRF in conjunction with IVIM MRI without contrast, there are typically no direct side effects associated with this procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor has come back or I have tissue damage from radiation.
Select...
I can take care of myself and perform daily activities.
Select...
I have never had a stroke or other brain blood vessel issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within the total 30-45 minute scan time
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the total 30-45 minute scan time
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of T1 relaxation times
Comparison of T2 relaxation times
Comparison of blood perfusion in brain tissues
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Participants with Tumor RecurrenceExperimental Treatment1 Intervention
The MRI scans (MRF and IVIM) will be performed on participants with newly developed recurrent prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings
Group II: Participants with Radiation NecrosisExperimental Treatment1 Intervention
The MRI scans (MRF and IVIM) will be performed on participants with newly developed necrosis prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings
Group III: Healthy Volunteer ParticipantsExperimental Treatment1 Intervention
Healthy volunteers will be recruited to evaluate the capability of MRF in conjunction with intravoxel incoherent motion (IVIM) MRI and serve as healthy control data to compare with the participant data.
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
468 Previous Clinical Trials
33,396 Total Patients Enrolled
The Cleveland ClinicOTHER
1,053 Previous Clinical Trials
1,371,134 Total Patients Enrolled
Samuel Chao, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
2 Previous Clinical Trials
163 Total Patients Enrolled
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