NCT03680144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

September 19, 2018

Last Update Submit

April 21, 2026

Conditions

Invasive Malignant NeoplasmMetastatic Malignant Neoplasm in the Brain

Outcome Measures

Primary Outcomes (4)

  • Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative cerebral blood volume (rCBV)

    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.

    Baseline up to 1 year

  • Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative peak height (rPH)

    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.

    Baseline up to 1 year

  • Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: percentage of signal intensity recovery (PSR)

    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.

    Baseline up to 1 year

  • Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: mean transit time (MTT)

    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.

    Baseline up to 1 year

Study Arms (1)

Diagnostic (MRI, DSC-MRI)

EXPERIMENTAL

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)Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Dynamic Susceptibility Contrast-MRI (DSC-MRI)PROCEDURE

Undergo DSC-MRI

Also known as: Dynamic Susceptibility Contrast-Enhanced MRI
Diagnostic (MRI, DSC-MRI)
Magnetic Resonance Imaging (MRI)PROCEDURE

Undergo diagnostic MRI

Also known as: MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (MRI, DSC-MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Hui-Kuo Shu, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 21, 2018

Study Start

November 28, 2018

Primary Completion

November 5, 2020

Study Completion

June 15, 2021

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

US(2)