Clinical trial NCT03698162: Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases
Official title: Area B: Precise DCE-MRI Assessment of Brain Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Metastases
Glioma of Brain
Brain Tumor
Metastatic Melanoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-10-05
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Volume transfer constant (Ktrans)
timeFrame: Up to 3 years
measure: Fractional plasma volume (vp)
timeFrame: Up to 3 years
measure: Fractional extravascular-extracellular space volume (ve)
timeFrame: Up to 3 years
measure: Model-free initial area under the contrast agent concentration curve (iAUC)
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Krishna Nayak, PhD
role: PRINCIPAL_INVESTIGATOR
References: