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

• ClinicalTrials.gov Identifier: NCT02277561
• Recruitment Status: Withdrawn
• First Posted: October 29, 2014
• Last Update Posted: March 4, 2020
• Sponsor: Albert Einstein College of Medicine
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Madhur Garg, Albert Einstein College of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tumors Metastatic to Brain; Unspecified Adult Solid Tumor, Protocol Specific	Procedure: diffusion tensor imaging; Radiation: whole-brain radiation therapy; Radiation: stereotactic radiosurgery; Procedure: contrast-enhanced magnetic resonance imaging; Procedure: diffusion-weighted magnetic resonance imaging	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prediction of Response of Brain Metastases to Brain Irradiation Using Voxel Based Diffusion Tensor Imaging
• Study Start Date: April 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Procedure: diffusion tensor imaging; Undergo VB-DTI; Radiation: whole-brain radiation therapy; Undergo WBRT; Other Names: WBRT; whole-brain radiotherapy; Radiation: stereotactic radiosurgery; Undergo SRS; Procedure: contrast-enhanced magnetic resonance imaging; Undergo contrast-enhanced MRI; Other Name: Contrast-enhanced MRI; Procedure: diffusion-weighted magnetic resonance imaging; Undergo DW MRI; Other Name: diffusion-weighted MRI

Outcome Measures

Primary Outcome Measures :

1. Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion [ Time Frame: Up to 3 years ]
2. Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion [ Time Frame: At 4 months ]
   Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05.
3. Volumetric radiographic response for each lesion [ Time Frame: At 4 months ]
   Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05. Statistical significance will be achieved with a p value < 0.05.
4. Change in a lesion's overall mean ADC [ Time Frame: Baseline to 4 months ]
   Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05. Statistical significance will be achieved with a p value < 0.05.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Albert Einstein College of Medicine

Bronx, New York, United States, 10461

Sponsors and Collaborators

Albert Einstein College of Medicine

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Madhur Garg; Montefiore Medical Center

More Information

• Responsible Party: Madhur Garg, Principal Investigator, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT02277561
• Other Study ID Numbers: 13-01-047; NCI-2014-01015 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 13-01-047 ( Other Identifier: Albert Einstein College of Medicine ); P30CA013330 ( U.S. NIH Grant/Contract )
• First Posted: October 29, 2014
• Last Update Posted: March 4, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Neoplasms