- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04246879
MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
April 1, 2024 updated by: Duke University
Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
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).
Study Overview
Study Type
Interventional
Enrollment (Estimated)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eileen Duffy, RN OCN
- Phone Number: 919 668 3726
- Email: eileen.duffy@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Health System
-
Contact:
- Eileen Duffy, BNS RN OCN
- Phone Number: 919-668-3726
-
Principal Investigator:
- Scott Floyd, MD PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRI
|
Subjects undergo one additional delayed MRI sequence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of positive MRI sequences along with positive tumor biopsies
Time Frame: baseline
|
true tumor will be detected by delayed MRI as determined by biopsy
|
baseline
|
number of negative MRI sequences along with negative tumor biopsies
Time Frame: baseline
|
absence of tumor will be detected by delayed MRI as determined by biopsy
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Scott Floyd, M.D. Ph.D., Duke Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 19, 2021
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
January 28, 2020
First Submitted That Met QC Criteria
January 28, 2020
First Posted (Actual)
January 29, 2020
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00103163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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