Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05559853
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ouri Cohen, PhD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Brain Metastases, Adult, Metastatic Brain Tumor, Metastatic Brain Cancer
Study Website:	View Trial Website

Arms & Interventions

Arms

: Participants with Brain Metastases

Participants will have at least one untreated brain metastasis > 1cm

: Healthy participants

Participants will have no known cancer diagnosis

Interventions

Diagnostic Test: - CEST-MRF

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Site Contact

Ouri Coheb, PhD

[email protected]

646-608-8259