Voxel Based Diffusion Tensor Imaging in Predicting Response in Patients With Brain Metastases Undergoing Whole Brain Radiation Therapy or Stereotactic Radiosurgery

Withdrawn before enrolling · Not applicable

Conditions studied: Tumors Metastatic to Brain, Unspecified Adult Solid Tumor, Protocol Specific

In brief

This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting response in patients with brain metastases undergoing whole-brain radiation therapy or stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may allow doctors to measure response to whole brain radiation therapy or stereotactic radiosurgery earlier than is possible with a standard magnetic resonance imaging. The earlier ability to measure response may allow for consideration of alternative therapies at an earlier stage.

Key facts

Study ID

NCT02277561

Run by

Albert Einstein College of Medicine

People needed

0

Starts

2013-04-01

Expected to finish

2014-12-01

Last updated by the study team

2020-03-04

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with multiple lesions from solid tumors on clinical MRI diagnosing the brain metastases may be treated with either WBRT or SRS if clinically indicated at the time of presentation but not both
• Karnofsky performance status (KPS) >= 70
• Patients presenting with brain metastases from a newly diagnosed cancer may have systemic disease (brain disease at the time of initial cancer diagnosis)
• Patients with a history of cancer, but newly diagnosed brain metastases must have clinically stable systemic disease
• If a biopsy is performed, the patient has to be at least 1 week post-biopsy
• The patient must be able to commit to diffusion-weighted magnetic resonance (MR) imaging, diffusion tensor imaging (DTI), and chemical shift imaging (CSI) prior to treatment, after the first week of treatment, and 7-11 days after the completion of treatment at the Magnetic Resonance Research Center (MRRC)
• Patients undergoing SRS without WBRT must be able to commit to diffusion-weighted MR imaging, DTI, and CSI prior to treatment, and 7-11 days after the completion of the SRS treatment at the MRRC
• The patient must also be able to commit to post-treatment follow-up visits at Montefiore Medical Center involving serial MR imaging; the follow-up visits are to occur bimonthly for 6 months and then every 6 months until death

You may not qualify if…

• Any medical condition, which would make the imaging studies or WBRT unsafe or poorly tolerated
• Patient is receiving concurrent chemotherapy
• Known allergic reaction to contrast or shellfish
• Patients with brain metastases to be treated with radiosurgery
• Patients with brain metastasis resulting from hematologic malignancies and small cell lung cancer
• Implanted metal devices or foreign bodies that serve as a contraindication to MR imaging
• Creatinine > 1.4 mg/dl and creatinine clearance < 20 mg/dl
• Uncontrolled, clinically significant cardiac arrhythmias
• Severe claustrophobia
• Pregnant female
• Any prior radiation therapy to the brain
• KPS < 70
• Patients with leptomeningeal disease

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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