Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases

  • STATUS
    Recruiting
  • End date
    Apr 13, 2024
  • participants needed
    150
  • sponsor
    University of Southern California
Updated on 26 October 2021

Summary

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.

Description

PRIMARY OBJECTIVES:

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.

Details
Condition Intracranial Glioma, brain tumors, Brain Tumor (Pediatric), Malignant neoplasm of brain, Glioma of Brain, Metastatic Melanoma, Brain Metastasis, Brain Tumor, Brain Metastases, Stage IV Melanoma, Brain Cancer
Treatment dynamic contrast-enhanced magnetic resonance imaging, Bevacizumab Injection
Clinical Study IdentifierNCT03698162
SponsorUniversity of Southern California
Last Modified on26 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 I: Pregnant women, prisoners, and institutionalized individuals will be excluded
COHORT II: Exclusion criteria include treatment with any other anti-cancer treatment, and other immunotherapy exclusion criteria
COHORT II: Non-cutaneous melanomas will be excluded
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 II: Pregnant women, prisoners, and institutionalized individuals will be excluded
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