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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

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ClinicalTrials.gov Identifier: NCT02277561
Recruitment Status : Withdrawn (IRB approved but never implemented)
First Posted : October 29, 2014
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Madhur Garg, Albert Einstein College of Medicine

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.

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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

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277561


Locations
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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
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Principal Investigator: Madhur Garg Montefiore Medical Center
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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    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Neoplasms