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

NCT01974804 | Completed

• 1 other identifier: 13-094
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Cancer

Keywords

MRI; Brain metastases; 13-094

Outcome Measures

Primary Outcomes (1)

• feasibility of diffusion and perfusion magnetic resonance imaging (MRI)

  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.

  1 year

Study Arms (1)

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

Interventions

MRI PROCEDURE

Pts having an MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kathryn Beal, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 4, 2013
• Study Start: October 25, 2013
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

US (1)