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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Brain Metastases | Participants will have at least one untreated brain metastasis > 1cm |
| |
| Healthy participants | Participants will have no known cancer diagnosis. Volunteers enrolled on this protocol may undergo multiple MRI examinations periodically for studies of reproducibility. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEST-MRF | Diagnostic Test | CEST-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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Create CEST-MRF parameter maps | Develop an MRI physics-guided artificial intelligence approach to improve acquisition and reconstruction of multiparametric data | Up to 3 years |
| Measure longitudinal changes in CEST-MRF after SRS |
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Inclusion Criteria:
Healthy volunteers [for Study Aim 1 (SA1) and Study Aim 2 (SA2)] will be entered into the study if they meet the following criteria:
Patients [for Study Aim 1 (SA1)] will be entered into the study if they meet the following criteria:
Patients [for Study Aim 3 (SA3)] will be entered into the study if they meet the following criteria:
Exclusion Criteria:
Healthy volunteers (SA1 & SA2) and patients (SA1 & SA3) exclusion criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ouri Cohen, PhD | Contact | 646-608-8259 | coheno1@mskcc.org | |
| Nelson Moss, MD | Contact | 212-639-7075 | mossn@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Ouri Cohen, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Evaluate CEST-MRF changes before and after radiation therapy to assess potential role as predictive imaging biomarker for brain metastases
| Up to 3 years |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |