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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01974804
Recruitment Status : Active, not recruiting
First Posted : November 3, 2013
Last Update Posted : March 13, 2020
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Cancer Procedure: MRI

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis
Study Start Date : October 2013
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Group/Cohort Intervention/treatment
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..
Procedure: MRI

Primary Outcome Measures :
  1. feasibility of diffusion and perfusion magnetic resonance imaging (MRI) [ Time Frame: 1 year ]
    This is a technology assessment protocol for response to treatment. The study is designed to assess the utility of the technology using a limited number of participants. We will assess whether the MR parameters are predictive markers of early response.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The protocol investigators on the study will identify potential research participants from those patients who are scheduled for MRI examination as part of their routine clinical care.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01974804

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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Kathryn Beal, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT01974804    
Other Study ID Numbers: 13-094
First Posted: November 3, 2013    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Brain metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases