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Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis

Study Purpose

Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if new imaging methods can help tumor evaluation in the brain. The extra images will be obtained using diffusion and perfusion MRI techniques to assess early treatment response in patients with brain metastasis, and will be compared to methods currently being used.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
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:

  • - Adults aged 18 and over.
  • - Patients/Subjects able to give informed consent - Patients/Subjects whose weight does not exceed 275 lbs.
  • - Patient with metastatic brain tumors greater than or equal to 1.0 cm that will be treated with stereotactic radiosurgery and scheduled for an MRI scan as part of their routine care

    Exclusion Criteria:

    - Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.

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.

NCT01974804
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.

Kathryn Beal, MD
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 Cancer
Study Website: View Trial Website
Arms & Interventions

Arms

: Pts having an MRI

Patients will undergo a 20 minute pretreatment MRI scan and a 30 minute post treatment MRI scan with contrast agent administration. Ten patients with brain metastasis will be recruited in the study. All the patients will be undergoing SRS (Stereotactic Radiosurgery). Patients will have 1 pretreatment evaluation and 2 post treatment evaluations [1-72 hours post treatment and 8 weeks (+/- 2 weeks) post treatment] for early response. Patients are to be administered contrast prior to obtaining MRI scans. These research scans are estimated to take 20 minutes of scan time (+/- 10 minutes), which includes patient set up and conducting the research sequences..

Interventions

Procedure: - MRI

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.

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Kathryn Beal, MD

212-639-5159