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

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02277561
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Location
1
Arm
20
Duration (Months)
0
Patients Per Site Per Month

Study Details

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
  • Procedure: diffusion tensor imaging
  • Radiation: whole-brain radiation therapy
  • Radiation: stereotactic radiosurgery
  • Procedure: contrast-enhanced magnetic resonance imaging
  • Procedure: diffusion-weighted magnetic resonance imaging
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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
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 :
Apr 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 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 Names:
  • Contrast-enhanced MRI

    • Procedure: diffusion-weighted magnetic resonance imaging
    Undergo DW MRI
    Other Names:
  • diffusion-weighted MRI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion [Up to 3 years]

    2. Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion [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 [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 [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

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    • 13-01-047
    • P30CA013330
    First Posted:
    Oct 29, 2014
    Last Update Posted:
    Mar 4, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Brain Neoplasms

    Study Results

    No Results Posted as of Mar 4, 2020