Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03680144
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hui-Kuo Shu, MD, PhD, Emory University

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.

Condition or disease Intervention/treatment Phase
Invasive Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain Procedure: Dynamic Susceptibility Contrast-MRI (DSC-MRI) Procedure: Magnetic Resonance Imaging (MRI) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : August 17, 2020
Estimated Study Completion Date : August 17, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Dynamic Susceptibility Contrast-MRI (DSC-MRI)
Undergo DSC-MRI
Other Name: Dynamic Susceptibility Contrast-Enhanced MRI

Procedure: Magnetic Resonance Imaging (MRI)
Undergo diagnostic MRI
Other Names:
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging




Primary Outcome Measures :
  1. Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative cerebral blood volume (rCBV) [ Time Frame: Baseline up to 1 year ]
    Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. rCBV is calculated as the ratio of the CBV within the enhancing region to the CBV within the contralateral normal-appearing white matter.

  2. Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative peak height (rPH) [ Time Frame: Baseline up to 1 year ]
    Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. rPH is defined as the maximal change in contrast signal intensity from pre-contrast baseline compared to the lowest signal intensity during contrast bolus, normalized to the signal in the contralateral normal-appearing white matter.

  3. Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: percentage of signal intensity recovery (PSR) [ Time Frame: Baseline up to 1 year ]
    Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. PSR is defined as the percentage of the difference between lowest signal intensity during contrast bolus and the recovery post-contrast signal intensity compared to the peak height.

  4. Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: mean transit time (MTT) [ Time Frame: Baseline up to 1 year ]
    Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. MTT is defined as the average time in which contrast passes through a given region of brain tissue and is estimated from the contrast concentration-time course curve (CC-TCC) as width of the curve at half maximum height.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680144


Contacts
Layout table for location contacts
Contact: Hui-Kuo Shu, MD, PhD 404-778-3473 hgshu@emory.edu
Contact: Robert Press, MD 404-778-3473 rhpress@emory.edu

Locations
Layout table for location information
United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Giesla Rodgers    404-778-5162    grodg01@emory.edu   
Emory Saint Joseph's Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Alicia Escobar    678-843-7029    alicia.m.escobar@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Hui-Kuo Shu, MD, PhD Emory University
Layout table for additonal information
Responsible Party: Hui-Kuo Shu, MD, PhD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03680144    
Other Study ID Numbers: IRB00102506
NCI-2018-01722 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RAD4391-18 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Necrosis
Neoplasms
Pathologic Processes