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MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04246879
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE January 29, 2020
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE October 6, 2020
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
Official Title  ICMJE Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Brain Metastases
Intervention  ICMJE Other: MRI
Subjects undergo one additional delayed MRI sequence
Study Arms  ICMJE Experimental: MRI
Intervention: Other: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2020)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joan Cahill, BNS RN OCN CCRP 919 668 5211 joan.cahill@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04246879
Other Study ID Numbers  ICMJE Pro00103163
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Floyd, M.D. Ph.D. Duke Health
PRS Account Duke University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP