Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases
NCT ID: NCT03698162
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2021-04-13
2025-03-01
Brief Summary
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Detailed Description
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I. To optimize and technically validate specially-tailored acquisition and reconstruction (STAR) DCE-MRI based on the accuracy and reproducibility of whole-brain tracer-kinetic (TK) parameter maps.
SECONDARY OBJECTIVES:
I. To develop a robust clinical implementation of STAR DCE-MRI. II. To clinically evaluate STAR DCE-MRI in patients with brain tumors.
OUTLINE: Participants are assigned to 1 of 2 cohorts.
COHORT I: Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months, and just prior to and 4-6 weeks after starting bevacizumab treatment. If there is concern for tumor progression (i.e. increased contrast enhancement), more frequent MRI scans will be scheduled.
COHORT II: Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for tumor progression.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort I (STAR DCE-MRI)
Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months, and just prior to and 4-6 weeks after starting bevacizumab treatment. Participants may undergo more frequent MRI if there is concern for tumor progression.
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo STAR DCE-MRI
Bevacizumab Injection
Bevacizumab will be give to participants who have recurrent high-grade glioma as part of standard of care.
Cohort II (STAR DCE-MRI)
Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for tumor progression.
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo STAR DCE-MRI
Interventions
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Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo STAR DCE-MRI
Bevacizumab Injection
Bevacizumab will be give to participants who have recurrent high-grade glioma as part of standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* COHORT I: We will include adult patients with histopathologically confirmed high-grade glioma with evidence of tumor progression at baseline MRI who will undergo treatment with an anti-angiogenic agent (bevacizumab) with or without concomitant chemotherapy, and Karnofsky Performance Score \> 60%.
* COHORT I: At least 30 days should have elapsed since prior therapy including surgery and temozolomide chemoradiation.
* COHORT I: Satisfactory renal, hepatic, and hematologic function is required.
* COHORT II: Melanoma brain metastases (often small and spread throughout the brain) treated with immunotherapy.
* COHORT II: We will include adult patients with a tissue-proven history of melanoma who have contrast enhancing brain masses who will undergo treatment with immunotherapy with an anti-CTLA-4 or anti-PD-1 approach (e.g. ipilimumab, pembrolizumab, or nivolumab), and Karnofsky Performance Score \> 60%.
* COHORT II: At least 30 days should have elapsed since prior therapy including surgery, stereotactic brain irradiation, and corticosteroid use.
Exclusion Criteria
* COHORT II: Non-cutaneous melanomas will be excluded.
* COHORT II: Pregnant women, prisoners, and institutionalized individuals will be excluded.
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Krishna Nayak, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2018-01890
Identifier Type: REGISTRY
Identifier Source: secondary_id
6B-17-2
Identifier Type: OTHER
Identifier Source: secondary_id
6B-17-2
Identifier Type: -
Identifier Source: org_study_id
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