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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

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diffusion tensor imaging
whole-brain radiation therapy
stereotactic radiosurgery
contrast-enhanced magnetic resonance imaging
diffusion-weighted magnetic resonance imaging
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tumors Metastatic to Brain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (VB-DTI, MRI)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 27, 2014
Last Updated
March 2, 2020
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02277561
Brief Title
Voxel Based Diffusion Tensor Imaging in Predicting Response in Patients With Brain Metastases Undergoing Whole Brain Radiation Therapy or Stereotactic Radiosurgery
Official Title
Prediction of Response of Brain Metastases to Brain Irradiation Using Voxel Based Diffusion Tensor Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
IRB approved but never implemented
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors Metastatic to Brain, Unspecified Adult Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (VB-DTI, MRI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
diffusion tensor imaging
Intervention Description
Undergo VB-DTI
Intervention Type
Radiation
Intervention Name(s)
whole-brain radiation therapy
Other Intervention Name(s)
WBRT, whole-brain radiotherapy
Intervention Description
Undergo WBRT
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Intervention Description
Undergo SRS
Intervention Type
Procedure
Intervention Name(s)
contrast-enhanced magnetic resonance imaging
Other Intervention Name(s)
Contrast-enhanced MRI
Intervention Description
Undergo contrast-enhanced MRI
Intervention Type
Procedure
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
diffusion-weighted MRI
Intervention Description
Undergo DW MRI
Primary Outcome Measure Information:
Title
Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion
Time Frame
Up to 3 years
Title
Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion
Description
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.
Time Frame
At 4 months
Title
Volumetric radiographic response for each lesion
Description
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.
Time Frame
At 4 months
Title
Change in a lesion's overall mean ADC
Description
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.
Time Frame
Baseline to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhur Garg
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

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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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