Back to resultsMRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
Primary Purpose
Brain Metastases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional other trial for Brain Metastases focused on measuring Laser Interstitial Thermal Therapy (LITT), Stereotactic radiosurgery (SRS), Magnetic resonance image (MRI)
Eligibility Criteria
Inclusion Criteria:
- Adult patients, age ≥18
- Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
- Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
- Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
- Radiographic progression on post-SRS imaging at previously treated SRS site(s)
- Must be a candidate for LITT procedure as determined by treating neurosurgeon and/or anesthesia team
- Patients must sign study-specific informed consent prior to study entry
Exclusion Criteria:
- Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
- Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
- Small cell lung cancer (SCLC) or lymphoma histology
Sites / Locations
- Duke University Health SystemRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI
Arm Description
Outcomes
Primary Outcome Measures
number of positive MRI sequences along with positive tumor biopsies
true tumor will be detected by delayed MRI as determined by biopsy
number of negative MRI sequences along with negative tumor biopsies
absence of tumor will be detected by delayed MRI as determined by biopsy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04246879
Brief Title
MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
Official Title
Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Laser Interstitial Thermal Therapy (LITT), Stereotactic radiosurgery (SRS), Magnetic resonance image (MRI)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Subjects undergo one additional delayed MRI sequence
Primary Outcome Measure Information:
Title
number of positive MRI sequences along with positive tumor biopsies
Description
true tumor will be detected by delayed MRI as determined by biopsy
Time Frame
baseline
Title
number of negative MRI sequences along with negative tumor biopsies
Description
absence of tumor will be detected by delayed MRI as determined by biopsy
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, age ≥18
Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
Radiographic progression on post-SRS imaging at previously treated SRS site(s)
Must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team
Patients must sign study-specific informed consent prior to study entry
Exclusion Criteria:
Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
Small cell lung cancer (SCLC) or lymphoma histology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Cahill, BNS RN OCN
Phone
919 668 5211
Email
joan.cahill@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Floyd, M.D. Ph.D.
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Duffy, BNS RN OCN
Phone
919-668-3726
First Name & Middle Initial & Last Name & Degree
Scott Floyd, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
We'll reach out to this number within 24 hrs