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

NCT02277561 | Withdrawn DMC FDA Device

• 3 other identifiers: 13-01-047NCI-2014-01015P30CA013330
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion

  Up to 3 years

• Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion

  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.

  At 4 months

• Volumetric radiographic response for each lesion

  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.

  At 4 months

• Change in a lesion's overall mean ADC

  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.

  Baseline to 4 months

Study Arms (1)

Diagnostic (VB-DTI, MRI)

EXPERIMENTAL

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; Radiation: whole-brain radiation therapy; Radiation: stereotactic radiosurgery; Procedure: contrast-enhanced magnetic resonance imaging; Procedure: diffusion-weighted magnetic resonance imaging

Interventions

diffusion tensor imaging PROCEDURE

Undergo VB-DTI

Diagnostic (VB-DTI, MRI)

whole-brain radiation therapy RADIATION

Undergo WBRT

Also known as: WBRT, whole-brain radiotherapy

Diagnostic (VB-DTI, MRI)

stereotactic radiosurgery RADIATION

Undergo SRS

Diagnostic (VB-DTI, MRI)

contrast-enhanced magnetic resonance imaging PROCEDURE

Undergo contrast-enhanced MRI

Also known as: Contrast-enhanced MRI

Diagnostic (VB-DTI, MRI)

diffusion-weighted magnetic resonance imaging PROCEDURE

Undergo DW MRI

Also known as: diffusion-weighted MRI

Diagnostic (VB-DTI, MRI)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Diffusion Tensor Imaging; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Madhur Garg

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 29, 2014
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

US (1)