Brain MetastasesNCT05559853
Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
An observational study of Brain Metastases and Brain Metastases, Adult, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Metastases, Brain Metastases, Adult, Metastatic Brain Tumor
- What is being tested?
- CEST-MRF
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 22 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- Healthy volunteers [for Study Aim 1 (SA1) and Study Aim 2 (SA2)] 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 1 (SA1)] will be entered into the study if they meet the following criteria:
- Age ≥ 18 years
Show all 13Show fewer
- 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)
- 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
Who cannot join
- Healthy volunteers (SA1 \& SA2) and patients (SA1 \& SA3) 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Ouri Coheb, PhD, 646-608-8259, coheno1@mskcc.org
About this study
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).
- Conditions
- Brain Metastases, Brain Metastases, Adult, Metastatic Brain Tumor, Metastatic Brain Cancer
- Being tested
- CEST-MRF
- Keywords
- Brain Metastases, Healthy Volunteers, metastatic brain tumor, metastatic brain cancer, Brain Metastases, Adult, MRI, untreated brain metastasis, CEST-MRF, chemical exchange saturation transfer magnetic resonance fingerprinting, 22-191, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEST-MRFDiagnostic test
Also called chemical exchange saturation transfer magnetic resonance fingerprinting method
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Brain Metastases | Participants will have at least one untreated brain metastasis > 1cm Receives: Diagnostic Test: CEST-MRF | |
| Healthy participants | Participants will have no known cancer diagnosis. Volunteers enrolled on this protocol may undergo multiple MRI examinations periodically for studies of reproducibility. Receives: Diagnostic Test: CEST-MRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 3 years
Secondary outcomes (2)
Create CEST-MRF parameter maps
Develop an MRI physics-guided artificial intelligence approach to improve acquisition and reconstruction of multiparametric data
Measured: Up to 3 years
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
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start22 Sep 2022
- Primary completion22 Sep 2027 (estimated)
- Study completion22 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ouri Cohen, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559853
- Sponsor's protocol ID
- 22-191
- Status last verified
- Mar 2026
- First submitted
- 22 Sep 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Clinical CEST MR Fingerprinting Method for Treatment Response Assessment in Brain Metastases
- ClinicalTrials.gov ID
- NCT05559853
- Acronym / sponsor ID
- 22-191
- Conditions
- Brain Metastases, Brain Metastases, Adult, Metastatic Brain Tumor, Metastatic Brain Cancer
- Keywords
- Brain Metastases, Healthy Volunteers, metastatic brain tumor, metastatic brain cancer, Brain Metastases, Adult, MRI, untreated brain metastasis, CEST-MRF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 22 Sep 2027 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Brain Metastases | – | Diagnostic Test: CEST-MRFParticipants will have at least one untreated brain metastasis > 1cm |
| Healthy participants | – | Diagnostic Test: CEST-MRFParticipants will have no known cancer diagnosis. Volunteers enrolled on this protocol may undergo multiple MRI examinations periodically for studies of reproducibility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (13 listed)
- Healthy volunteers [for Study Aim 1 (SA1) and Study Aim 2 (SA2)] 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 1 (SA1)] will be entered into the study if they meet the following criteria:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEST-MRFAlso: chemical exchange saturation transfer magnetic resonance fingerprinting methodCEST-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. | Diagnostic test | Healthy participants, Participants with Brain Metastases |
Primary outcome
Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion
Time frame: Up to 3 years
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).
2 secondary outcomes
Create CEST-MRF parameter maps
Time frame: Up to 3 years
Measure longitudinal changes in CEST-MRF after SRS
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ouri Cohen, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases and Brain Metastases, Adult, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ouri Cohen, PhD (646-608-8259, coheno1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.