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

NCT ID: NCT02277561

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if voxel based diffusion tensor imaging will provide an early predictive assessment of therapy response, as compared to radiographic volumetric response criteria.

OUTLINE:

Patients undergoing whole-brain radiation therapy (WBRT) for a total of 10 fractions also undergo VB-DTI magnetic resonance imaging (MRI) at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing stereotactic radiosurgery (SRS) without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.

After completion of study, patients are followed up every 2 months for 6 months and then every 6 months until death.

Conditions

Tumors Metastatic to Brain; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (VB-DTI, MRI)

Patients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.

Group Type: EXPERIMENTAL

diffusion tensor imaging

Intervention Type: PROCEDURE

Undergo VB-DTI

whole-brain radiation therapy

Intervention Type: RADIATION

Undergo WBRT

stereotactic radiosurgery

Intervention Type: RADIATION

Undergo SRS

contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

Undergo contrast-enhanced MRI

diffusion-weighted magnetic resonance imaging

Intervention Type: PROCEDURE

Undergo DW MRI

Interventions

diffusion tensor imaging

Undergo VB-DTI

Intervention Type: PROCEDURE

whole-brain radiation therapy

Undergo WBRT

Intervention Type: RADIATION

stereotactic radiosurgery

Undergo SRS

Intervention Type: RADIATION

contrast-enhanced magnetic resonance imaging

Undergo contrast-enhanced MRI

Intervention Type: PROCEDURE

diffusion-weighted magnetic resonance imaging

Undergo DW MRI

Intervention Type: PROCEDURE

Other Intervention Names

WBRT; whole-brain radiotherapy; Contrast-enhanced MRI; diffusion-weighted MRI

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Madhur Garg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madhur Garg

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Other Identifiers

NCI-2014-01015

Identifier Type: REGISTRY

Identifier Source: secondary_id

13-01-047

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-01-047

Identifier Type: -

Identifier Source: org_study_id