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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03680144
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Emory University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hui-Kuo Shu, MD, PhD
Principal Investigator Affiliation	Emory University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Invasive Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

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

Undergo DSC-MRI

Procedure: - Magnetic Resonance Imaging (MRI)

Undergo diagnostic MRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Atlanta, Georgia

Status

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Emory Saint Joseph's Hospital, Atlanta, Georgia

Status

Address

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

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