Development of MRF for Characterization of Brain Tumors After Radiotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCase Comprehensive Cancer Center
About this trial
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, individuals with previously untreated 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. * To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18 - 60
No history of cerebrovascular disease
No cognitive impairments
Able to provide informed consent
Disqualifiers
Pregnant women OR lactating women
Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.
The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.
Trial design
Design model
Parallel
Treatments tested in this trial
MRF in conjunction with IVIM MRI without contrast
Procedure/SurgeryMRF in conjunction with IVIM MRI scan, without contrast.
Treatment groups
90 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Healthy Volunteer ParticipantsExperimental treatment 1 intervention
Group B: Participants with Radiation NecrosisExperimental treatment 1 intervention
Group C: Participants with Tumor RecurrenceExperimental treatment 1 intervention
Group D: Participants with Brain MetastasesExperimental treatment 1 intervention
Group E: Participants with Primary GliomasExperimental treatment 1 intervention
Group F: Participants with MeningiomasExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of T1 relaxation times
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T1 relaxation times. The difference in mean T1 between each cohort of participants will be measured.
Time frame
Within the total 30-45 minute scan time2
Comparison of T2 relaxation times
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T2 relaxation times. The difference in mean T2 between each cohort of participants will be measured.
Time frame
Within the total 30-45 minute scan time3
Comparison of proton density maps
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the MRF proton density maps of each cohort of participants. This will be compared using a t-test.
Time frame
Within the total 30-45 minute scan time4
Comparison of water diffusion in brain tissues
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the diffusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Time frame
Within the total 30-45 minute scan timeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Comprehensive Cancer Center
Lead sponsor
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov