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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2019-05-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Invasive Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (MRI, DSC-MRI)

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.

Group Type EXPERIMENTAL

Dynamic Susceptibility Contrast-MRI (DSC-MRI)

Intervention Type PROCEDURE

Undergo DSC-MRI

Magnetic Resonance Imaging (MRI)

Intervention Type PROCEDURE

Undergo diagnostic MRI

Interventions

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Dynamic Susceptibility Contrast-MRI (DSC-MRI)

Undergo DSC-MRI

Intervention Type PROCEDURE

Magnetic Resonance Imaging (MRI)

Undergo diagnostic MRI

Intervention Type PROCEDURE

Other Intervention Names

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Dynamic Susceptibility Contrast-Enhanced MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No