Utility of Perfusion MRI to Detect Radiation Necrosis in Patients With Brain Metastases

Emory University

Status: Completed

Conditions: Metastatic Malignant Neoplasm in the Brain; Invasive Malignant Neoplasm

Treatments: Procedure: Dynamic Susceptibility Contrast-MRI (DSC-MRI); Procedure: Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03680144

P30CA138292 (U.S. NIH Grant/Contract)

RAD4391-18 (Other Identifier)

NCI-2018-01722 (Registry Identifier)

IRB00102506

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Diagnostic (MRI, DSC-MRI)

Experimental group

Description:

Participants undergo diagnostic magnetic resonance imaging (MRI) with and without contrast and treatment planning dynamic susceptibility contrast-MRI (DSC-MRI) series before receiving SRS at 4-6 weeks after SRS, and then every 3 months unless clinically indicated sooner.

Treatment:

Procedure: Magnetic Resonance Imaging (MRI)

Procedure: Dynamic Susceptibility Contrast-MRI (DSC-MRI)