Brain Metastases Clinical Trial
Official title:
Development of a Clinical CEST MR Fingerprinting Method for Treatment Response Assessment in Brain Metastases
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).
Status | Recruiting |
Enrollment | 94 |
Est. completion date | September 22, 2027 |
Est. primary completion date | September 22, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Healthy volunteers [for Study Aim 1 (SA1)] will be entered into the study if they meet the following criteria: - Age = 18 years - Able to understand and give informed consent - No known cancer diagnosis Patients [for Study Aim 3 (SA3)] will be entered into the study if they meet the following criteria: - Age = 18 years - Able to understand and give informed consent - At least one untreated brain metastasis > 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist) - Planned SRS treatment Exclusion Criteria: Healthy volunteers (SA1) and patients (SA2) exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Up to 3 years |
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