Back to resultsResponse of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Primary Purpose
Brain Metastases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Metastases
Eligibility Criteria
Inclusion Criteria:
- Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic.
- At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR.
- Patient must be clinically eligible for and elect to be treated with GK alone without WBRT.
- Patient must be ≥ 18 years of age.
- Patient must have Karnofsky Performance Status (KPS) of at least 60
- Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies.
- Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
- Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
- Patient must not be pregnant or breastfeeding.
- Patient must not have an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
- Patient must not have melanoma.
- Patient must not have hemorrhagic lesions.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DSC-PMR
Arm Description
DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery
Outcomes
Primary Outcome Measures
Time to local progression of each treated and evaluable brain metastasis
Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.
Secondary Outcome Measures
Radiation necrosis
Radiation necrosis will be defined by pathology, when available. When no pathology is available, clinical diagnosis based on clinical course and management will be used.
Complete response
Complete response = no residue enhancing lesion on MRI
Elsewhere brain failure
Elsewhere brain failure = appearance of brain metastases outside of the prior radiosurgery region which can be diagnosed radiographically and does not required require pathological confirmation.
Clinical deterioration
Clinical deterioration will be assessed based on the Karnofsky Performance scale (KPS).
100=Normal no complaints; no evidence of disease.
90=Able to carry on normal activity; minor signs or symptoms of disease.
80=Normal activity with effort; some signs or symptoms of disease.
70=Cares for self; unable to carry on normal activity or to do active work.
60=Requires occasional assistance, but is able to care for most of his personal needs.
50=Requires considerable assistance and frequent medical care.
40=Disabled; requires special care and assistance.
30=Severely disabled; hospital admission is indicated although death not imminent.
20=Very sick; hospital admission necessary; active supportive treatment necessary.
10=Moribund; fatal processes progressing rapidly.
0=Dead
Full Information
NCT ID
NCT02311556
First Posted
December 4, 2014
Last Updated
February 22, 2017
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02311556
Brief Title
Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Official Title
Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 7, 2013 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
December 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSC-PMR
Arm Type
Experimental
Arm Description
DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery
Intervention Type
Device
Intervention Name(s)
dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging
Other Intervention Name(s)
DSC-PMR
Primary Outcome Measure Information:
Title
Time to local progression of each treated and evaluable brain metastasis
Description
Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.
Time Frame
At time of radiosurgery and after radiosurgery (approximately 1 week)
Secondary Outcome Measure Information:
Title
Radiation necrosis
Description
Radiation necrosis will be defined by pathology, when available. When no pathology is available, clinical diagnosis based on clinical course and management will be used.
Time Frame
Up to 1 year
Title
Complete response
Description
Complete response = no residue enhancing lesion on MRI
Time Frame
Up to 1 year
Title
Elsewhere brain failure
Description
Elsewhere brain failure = appearance of brain metastases outside of the prior radiosurgery region which can be diagnosed radiographically and does not required require pathological confirmation.
Time Frame
Up to 1 year
Title
Clinical deterioration
Description
Clinical deterioration will be assessed based on the Karnofsky Performance scale (KPS).
100=Normal no complaints; no evidence of disease.
90=Able to carry on normal activity; minor signs or symptoms of disease.
80=Normal activity with effort; some signs or symptoms of disease.
70=Cares for self; unable to carry on normal activity or to do active work.
60=Requires occasional assistance, but is able to care for most of his personal needs.
50=Requires considerable assistance and frequent medical care.
40=Disabled; requires special care and assistance.
30=Severely disabled; hospital admission is indicated although death not imminent.
20=Very sick; hospital admission necessary; active supportive treatment necessary.
10=Moribund; fatal processes progressing rapidly.
0=Dead
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic.
At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR.
Patient must be clinically eligible for and elect to be treated with GK alone without WBRT.
Patient must be ≥ 18 years of age.
Patient must have Karnofsky Performance Status (KPS) of at least 60
Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies.
Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
Patient must not be pregnant or breastfeeding.
Patient must not have an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
Patient must not have melanoma.
Patient must not have hemorrhagic lesions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayi Huang, M.D.
Organizational Affiliation
Washington University of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
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