Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases
Key facts
- Who runs it
- University of Southern California
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 15 people enrolled
- Started
- 13 Apr 2021
- Ended
- 1 Mar 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Bevacizumab Injection
- Record updated
- 5 August 2025
- Why it stopped
- Slow accrual
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- COHORT I: Recurrent high-grade glioma (often with thin areas of enhancement) treated with bevacizumab
- 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
Who cannot take part
- COHORT I: Exclusion criteria include treatment with any other anti-cancer treatment, enzyme-inducing antiepileptic agents, anticoagulant treatment, pregnancy, other anti-angiogenesis therapy and prior thrombo-embolic disorders
- COHORT I: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder
- COHORT II: Exclusion criteria include treatment with any other anti-cancer treatment, and other immunotherapy exclusion criteria
- COHORT II: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder
- COHORT I: Pregnant women, prisoners, and institutionalized individuals will be excluded
- COHORT II: Non-cutaneous melanomas will be excluded
- COHORT II: Pregnant women, prisoners, and institutionalized individuals will be excluded
Where in United States
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesNo longer taking part
About the trial
What the trial wants to find out
Dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) is a potentially powerful diagnostic tool for the management of brain cancer and other conditions in which the blood-brain barrier is compromised. This trial studies how well precise DCE MRI works in diagnosing participants with high grade glioma that has come back or melanoma that has spread to the brain. The specially-tailored acquisition and reconstruction (STAR) DCE MRI could provide improved assessment of brain tumor status and response to therapy.
The 2 groups in the trial
- Cohort I (STAR DCE-MRI)Treatment being tested
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.
Treatment: Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Bevacizumab Injection
- Cohort II (STAR DCE-MRI)Treatment being tested
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.
Treatment: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Area B: Precise DCE-MRI Assessment of Brain Tumors
- Record updated
- 5 August 2025