Clinical trial NCT03680144: Utility of Perfusion MRI to Detect Radiation Necrosis in Patients With Brain Metastases
Official title: Diagnostic Accuracy of Dynamic Susceptibility Contrast (DSC) Perfusion MRI to Determine Radiation Necrosis Versus Tumor Progression in Brain Metastases Treated With Stereotactic Radiosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invasive Malignant Neoplasm
Metastatic Malignant Neoplasm in the Brain
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2018-09-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial studies how well dynamic susceptibility contrast-magnetic resonance imaging (MRI) works in determining radiation necrosis and tumor progression in participants with cancer that has spread to the brain and are being treated with radiation therapy. Diagnostic procedures, such as dynamic susceptibility contrast-MRI, may improve the ability to determine indeterminate post-treatment changes seen on imaging after radiation therapy.

Detailed description: PRIMARY OBJECTIVE:

I. To prospectively determine the sensitivity and specificity of dynamic susceptibility contrast (DSC)-MRI parameters in detecting tumor recurrence versus radiation necrosis for brain metastases treated with stereotactic radiosurgery (SRS).

SECONDARY OBJECTIVES:

I. To correlate radiographic diagnoses with pathologic diagnoses when surgical resection is clinically indicated.

II. To correlate baseline relative cerebral blood volume (rCBV) values and other hemodynamic parameters with tumor primary histology.

III. To assess overall survival, local failure, distant brain failure and neurologic death.

OUTLINE:

Participants undergo a diagnostic MRI with and without contrast and treatment planning DSC perfusion MRI series before receiving SRS at 4-6 weeks after SRS, and then every 3 months unless clinically indicated sooner.

Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of invasive malignancy with at least radiographic evidence of intracranial disease as seen on MRI.
* At least one identifiable intracranial lesion ≥ 1 cm in diameter enrolled within 4 weeks of diagnosis.
* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

Exclusion Criteria:

* Planned whole-brain radiotherapy (WBRT) with boost.
* Leptomeningeal disease.
* Inadequate renal function (estimated glomerular filtration rate \[eGFR\] \> 30 ml/min/1.73 m²) or contrast allergy.
* Non-MRI compatible pacemaker with pacemaker dependence.

Primary outcomes:
measure: Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative cerebral blood volume (rCBV)
timeFrame: Baseline up to 1 year
measure: Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative peak height (rPH)
timeFrame: Baseline up to 1 year
measure: Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: percentage of signal intensity recovery (PSR)
timeFrame: Baseline up to 1 year
measure: Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: mean transit time (MTT)
timeFrame: Baseline up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Hui-Kuo Shu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: