Invasive Malignant NeoplasmNCT03680144
Utility of Perfusion MRI to Detect Radiation Necrosis in Patients With Brain Metastases
A study testing Dynamic Susceptibility Contrast-MRI (DSC-MRI) and Magnetic Resonance Imaging (MRI) in people with Invasive Malignant Neoplasm and Metastatic Malignant Neoplasm in the Brain, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Dynamic Susceptibility Contrast-MRI (DSC-MRI) and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Nov 2018to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- Dynamic Susceptibility Contrast-MRI (DSC-MRI), Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Susceptibility Contrast-MRI (DSC-MRI)Procedure or surgery
Also called Dynamic Susceptibility Contrast-Enhanced MRI
Undergo DSC-MRI
Magnetic Resonance Imaging (MRI)Procedure or surgery
Also called MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Undergo diagnostic MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Dynamic Susceptibility Contrast-MRI (DSC-MRI); Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start28 Nov 2018
- Primary completion5 Nov 2020
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hui-Kuo Shu, Emory University
- Investigators
- Hui-Kuo Shu, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680144
- Sponsor's protocol ID
- IRB00102506
- Other IDs
- NCI-2018-01722, RAD4391-18, P30CA138292
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2018
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03680144
- Acronym / sponsor ID
- IRB00102506
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (MRI, DSC-MRI) | Experimental | Procedure: Dynamic Susceptibility Contrast-MRI (DSC-MRI), Procedure: Magnetic Resonance Imaging (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Susceptibility Contrast-MRI (DSC-MRI)Also: Dynamic Susceptibility Contrast-Enhanced MRIUndergo DSC-MRI | Procedure or surgery | Diagnostic (MRI, DSC-MRI) |
| Magnetic Resonance Imaging (MRI)Also: MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance ImagingUndergo diagnostic MRI | Procedure or surgery | Diagnostic (MRI, DSC-MRI) |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Kuo Shu, MD, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Susceptibility Contrast-MRI (DSC-MRI) and Magnetic Resonance Imaging (MRI) in people with Invasive Malignant Neoplasm and Metastatic Malignant Neoplasm in the Brain, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative cerebral blood volume (rCBV) (time frame: Baseline up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.