Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to develop and test a new magnetic resonance imaging (MRI) technique to see if it can be used to tell the difference between tumor growth from worsening of cancer and growth from the effects of treatment in participants who have brain tumors treated with radiation therapy called stereotactic radiosurgery (SRS).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Able to understand and give informed consent
No known cancer diagnosis
Age ≥ 18 years
Disqualifiers
Pregnant or breastfeeding women
Pre-existing medical conditions, including the likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
Age < 18 years
Trial population
The study investigators will discuss participant potentially eligible for research participation within their interdisciplinary brain metastasis disease management team. These potential participants will then be contacted by their treating physician or investigator team. Study investigators will prioritize consenting participants who are planned to undergo SRS and, when possible, will attempt to coordinate the research scan with their clinically necessary MRI scans to minimize time and disruption for the participant.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
CEST-MRF
Diagnostic testCEST-MRF enables accurate quantification of both proton exchange rates and volume fractions in a fraction of the time required by conventional pulse sequences will be developed and optimized.
Treatment groups
119 Participants
are divided into 2 treatment groupsGroup A: Participants with Brain Metastases1 intervention
Group B: Healthy participants1 intervention
Trial outcomes
Primary outcomes
1
Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion
Develop a rapid and robust 3D CEST-MRF pulse sequence for clinical scanners using our preclinical CEST-MRF pulse sequence as a basis by evaluating the changes of the 6 CEST-MRF parameters with and without motion. These parameters include the water T1 and T2 relaxation (T1w,T2w), amide exchange rate (ksw) and volume fraction (fs) and the semi-solid exchange rate (kssw) and volume fraction (fss).
Time frame
Up to 3 yearsSecondary outcomes
1
Create CEST-MRF parameter maps
Develop an MRI physics-guided artificial intelligence approach to improve acquisition and reconstruction of multiparametric data
Time frame
Up to 3 years2
Measure longitudinal changes in CEST-MRF after SRS
Evaluate CEST-MRF changes before and after radiation therapy to assess potential role as predictive imaging biomarker for brain metastases
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov