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MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

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ClinicalTrials.gov Identifier: NCT04246879
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Brain Metastases Other: MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
Actual Study Start Date : July 19, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: MRI Other: MRI
Subjects undergo one additional delayed MRI sequence


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246879


Contacts
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Contact: Joan Cahill, BNS RN OCN CCRP 919 668 5211 joan.cahill@duke.edu

Locations
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United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Eileen Duffy, BNS OCN CCRP    919-668-3726      
Principal Investigator: Scott Floyd, MD PhD         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Scott Floyd, M.D. Ph.D. Duke Health
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04246879    
Other Study ID Numbers: Pro00103163
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Laser Interstitial Thermal Therapy (LITT)
Stereotactic radiosurgery (SRS)
Magnetic resonance image (MRI)
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases