Brain MetastasesNCT03698162
Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases
A study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Bevacizumab Injection in people with Brain Metastases and Glioma of Brain, run by University of Southern California at 1 site in United States.
Trial summary
Dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) is a potentially powerful diagnostic tool for the management of brain cancer and other conditions in which the blood-brain barrier is compromised. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Brain Metastases, Glioma of Brain, Brain Tumor
- What is being tested?
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Bevacizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 1 Mar 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COHORT I: Recurrent high-grade glioma (often with thin areas of enhancement) treated with bevacizumab.
- COHORT I: We will include adult patients with histopathologically confirmed high-grade glioma with evidence of tumor progression at baseline MRI who will undergo treatment with an anti-angiogenic agent (bevacizumab) with or without concomitant chemotherapy, and Karnofsky Performance Score > 60%.
- COHORT I: At least 30 days should have elapsed since prior therapy including surgery and temozolomide chemoradiation.
- COHORT I: Satisfactory renal, hepatic, and hematologic function is required.
- COHORT II: Melanoma brain metastases (often small and spread throughout the brain) treated with immunotherapy.
- COHORT II: We will include adult patients with a tissue-proven history of melanoma who have contrast enhancing brain masses who will undergo treatment with immunotherapy with an anti-CTLA-4 or anti-PD-1 approach (e.g. ipilimumab, pembrolizumab, or nivolumab), and Karnofsky Performance Score > 60%.
- COHORT II: At least 30 days should have elapsed since prior therapy including surgery, stereotactic brain irradiation, and corticosteroid use.
Who cannot join
- COHORT I: Exclusion criteria include treatment with any other anti-cancer treatment, enzyme-inducing antiepileptic agents, anticoagulant treatment, pregnancy, other anti-angiogenesis therapy and prior thrombo-embolic disorders.
- COHORT I: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder.
- COHORT I: Pregnant women, prisoners, and institutionalized individuals will be excluded.
- COHORT II: Exclusion criteria include treatment with any other anti-cancer treatment, and other immunotherapy exclusion criteria.
- COHORT II: Non-cutaneous melanomas will be excluded.
- COHORT II: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder.
- COHORT II: Pregnant women, prisoners, and institutionalized individuals will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Area B: Precise DCE-MRI Assessment of Brain Tumors
Dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) is a potentially powerful diagnostic tool for the management of brain cancer and other conditions in which the blood-brain barrier is compromised. This trial studies how well precise DCE MRI works in diagnosing participants with high grade glioma that has come back or melanoma that has spread to the brain. The specially-tailored acquisition and reconstruction (STAR) DCE MRI could provide improved assessment of brain tumor status and response to therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To optimize and technically validate specially-tailored acquisition and reconstruction (STAR) DCE-MRI based on the accuracy and reproducibility of whole-brain tracer-kinetic (TK) parameter maps.
SECONDARY OBJECTIVES:
- To develop a robust clinical implementation of STAR DCE-MRI. II. To clinically evaluate STAR DCE-MRI in patients with brain tumors.
OUTLINE: Participants are assigned to 1 of 2 cohorts.
COHORT I: Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months, and just prior to and 4-6 weeks after starting bevacizumab treatment. If there is concern for tumor progression (i.e. increased contrast enhancement), more frequent MRI scans will be scheduled.
COHORT II: Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for tumor progression.
- Conditions
- Brain Metastases, Glioma of Brain, Brain Tumor, Metastatic Melanoma
- Being tested
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Bevacizumab Injection
- Medical subject headings
- Brain Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Contrast-Enhanced Magnetic Resonance ImagingOther
Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo STAR DCE-MRI
Bevacizumab InjectionOther
Also called Avastin
Bevacizumab will be give to participants who have recurrent high-grade glioma as part of standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (STAR DCE-MRI) | Experimental | Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months, and just prior to and 4-6 weeks after starting bevacizumab treatment. Participants may undergo more frequent MRI if there is concern for tumor progression. Receives: Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Bevacizumab Injection |
| Cohort II (STAR DCE-MRI) | Experimental | Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for tumor progression. Receives: Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume transfer constant (Ktrans)
The raw data will be acquired at the voxel level. Then the analytic parameters will be extracted from voxel-wise data such as the mean, median, interquartile range, skewness and kurtosis. Receiver-operating characteristic curves (ROC) will be used to illustrate the univariate prediction accuracy for each parameter in predicting the clinically determined outcome. The pattern of change with different clinical response status will be visually illustrated using spaghetti plots or other graphical approaches. Classification and Regression Tree (CART) with 10-fold cross validation will be used for building the final prediction model and determine the diagnostic cut point(s). CART analysis will also include demographics, comorbidity information, and relevant biological variables including sex. The final model accuracy will be assessed using area under the curve (AUC) when fitting a ROC curve using predicted outcome against the actual outcome.
Measured: Up to 3 years
Fractional plasma volume (vp)
The raw data will be acquired at the voxel level. Then the analytic parameters will be extracted from voxel-wise data such as the mean, median, interquartile range, skewness and kurtosis. ROC will be used to illustrate the univariate prediction accuracy for each parameter in predicting the clinically determined outcome. The pattern of change with different clinical response status will be visually illustrated using spaghetti plots or other graphical approaches. CART with 10-fold cross validation will be used for building the final prediction model and determine the diagnostic cut point(s). CART analysis will also include demographics, comorbidity information, and relevant biological variables including sex. The final model accuracy will be assessed using AUC when fitting a ROC curve using predicted outcome against the actual outcome.
Measured: Up to 3 years
Fractional extravascular-extracellular space volume (ve)
The raw data will be acquired at the voxel level. Then the analytic parameters will be extracted from voxel-wise data such as the mean, median, interquartile range, skewness and kurtosis. ROC will be used to illustrate the univariate prediction accuracy for each parameter in predicting the clinically determined outcome. The pattern of change with different clinical response status will be visually illustrated using spaghetti plots or other graphical approaches. CART with 10-fold cross validation will be used for building the final prediction model and determine the diagnostic cut point(s). CART analysis will also include demographics, comorbidity information, and relevant biological variables including sex. The final model accuracy will be assessed using AUC when fitting a ROC curve using predicted outcome against the actual outcome.
Measured: Up to 3 years
Model-free initial area under the contrast agent concentration curve (iAUC)
The raw data will be acquired at the voxel level. Then the analytic parameters will be extracted from voxel-wise data such as the mean, median, interquartile range, skewness and kurtosis. ROC will be used to illustrate the univariate prediction accuracy for each parameter in predicting the clinically determined outcome. The pattern of change with different clinical response status will be visually illustrated using spaghetti plots or other graphical approaches. CART with 10-fold cross validation will be used for building the final prediction model and determine the diagnostic cut point(s). CART analysis will also include demographics, comorbidity information, and relevant biological variables including sex. The final model accuracy will be assessed using AUC when fitting a ROC curve using predicted outcome against the actual outcome.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start13 Apr 2021
- Primary completion22 Nov 2023
- Study completion1 Mar 2025
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Krishna Nayak, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698162
- Sponsor's protocol ID
- 6B-17-2
- Other IDs
- NCI-2018-01890, 6B-17-2, P30CA014089, R33CA225400
- Status last verified
- Jun 2025
- First submitted
- 1 Oct 2018
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Area B: Precise DCE-MRI Assessment of Brain Tumors
- ClinicalTrials.gov ID
- NCT03698162
- Acronym / sponsor ID
- 6B-17-2
- Conditions
- Brain Metastases, Glioma of Brain, Brain Tumor, Metastatic Melanoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 5 Oct 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.
Dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) is a potentially powerful diagnostic tool for the management of brain cancer and other conditions in which the blood-brain barrier is compromised. This trial studies how well precise DCE MRI works in diagnosing participants with high grade glioma that has come back or melanoma that has spread to the brain. The specially-tailored acquisition and reconstruction (STAR) DCE MRI could provide improved assessment of brain tumor status and response to therapy.
Detailed description
PRIMARY OBJECTIVES:
- To optimize and technically validate specially-tailored acquisition and reconstruction (STAR) DCE-MRI based on the accuracy and reproducibility of whole-brain tracer-kinetic (TK) parameter maps.
SECONDARY OBJECTIVES:
- To develop a robust clinical implementation of STAR DCE-MRI. II. To clinically evaluate STAR DCE-MRI in patients with brain tumors.
OUTLINE: Participants are assigned to 1 of 2 cohorts.
COHORT I: Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months, and just prior to and 4-6 weeks after starting bevacizumab treatment. If there is concern for tumor progression (i.e. increased contrast enhancement), more frequent MRI scans will be scheduled.
COHORT II: Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for tumor progression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (STAR DCE-MRI) | Experimental | Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Other: Bevacizumab InjectionParticipants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months, and just prior to and 4-6 weeks after starting bevacizumab treatment. Participants may undergo more frequent MRI if there is concern for tumor progression. |
| Cohort II (STAR DCE-MRI) | Experimental | Other: Dynamic Contrast-Enhanced Magnetic Resonance ImagingParticipants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for tumor progression. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- COHORT I: Recurrent high-grade glioma (often with thin areas of enhancement) treated with bevacizumab.
- COHORT I: We will include adult patients with histopathologically confirmed high-grade glioma with evidence of tumor progression at baseline MRI who will undergo treatment with an anti-angiogenic agent (bevacizumab) with or without concomitant chemotherapy, and Karnofsky Performance Score > 60%.
- COHORT I: At least 30 days should have elapsed since prior therapy including surgery and temozolomide chemoradiation.
- COHORT I: Satisfactory renal, hepatic, and hematologic function is required.
- COHORT II: Melanoma brain metastases (often small and spread throughout the brain) treated with immunotherapy.
Key exclusion criteria (7 listed)
- COHORT I: Exclusion criteria include treatment with any other anti-cancer treatment, enzyme-inducing antiepileptic agents, anticoagulant treatment, pregnancy, other anti-angiogenesis therapy and prior thrombo-embolic disorders.
- COHORT I: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder.
- COHORT I: Pregnant women, prisoners, and institutionalized individuals will be excluded.
- COHORT II: Exclusion criteria include treatment with any other anti-cancer treatment, and other immunotherapy exclusion criteria.
- COHORT II: Non-cutaneous melanomas will be excluded.
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 Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo STAR DCE-MRI | Other | Cohort I (STAR DCE-MRI), Cohort II (STAR DCE-MRI) |
| Bevacizumab InjectionAlso: AvastinBevacizumab will be give to participants who have recurrent high-grade glioma as part of standard of care. | Other | Cohort I (STAR DCE-MRI) |
Primary outcome
Volume transfer constant (Ktrans)
Time frame: Up to 3 years
The raw data will be acquired at the voxel level. Then the analytic parameters will be extracted from voxel-wise data such as the mean, median, interquartile range, skewness and kurtosis. Receiver-operating characteristic curves (ROC) will be used to illustrate the univariate prediction accuracy for each parameter in predicting the clinically determined outcome. The pattern of change with different clinical response status will be visually illustrated using spaghetti plots or other graphical approaches. Classification and Regression Tree (CART) with 10-fold cross validation will be used for building the final prediction model and determine the diagnostic cut point(s). CART analysis will also include demographics, comorbidity information, and relevant biological variables including sex. The final model accuracy will be assessed using area under the curve (AUC) when fitting a ROC curve using predicted outcome against the actual outcome.
Fractional plasma volume (vp)
Time frame: Up to 3 years
The raw data will be acquired at the voxel level. Then the analytic parameters will be extracted from voxel-wise data such as the mean, median, interquartile range, skewness and kurtosis. ROC will be used to illustrate the univariate prediction accuracy for each parameter in predicting the clinically determined outcome. The pattern of change with different clinical response status will be visually illustrated using spaghetti plots or other graphical approaches. CART with 10-fold cross validation will be used for building the final prediction model and determine the diagnostic cut point(s). CART analysis will also include demographics, comorbidity information, and relevant biological variables including sex. The final model accuracy will be assessed using AUC when fitting a ROC curve using predicted outcome against the actual outcome.
Fractional extravascular-extracellular space volume (ve)
Time frame: Up to 3 years
The raw data will be acquired at the voxel level. Then the analytic parameters will be extracted from voxel-wise data such as the mean, median, interquartile range, skewness and kurtosis. ROC will be used to illustrate the univariate prediction accuracy for each parameter in predicting the clinically determined outcome. The pattern of change with different clinical response status will be visually illustrated using spaghetti plots or other graphical approaches. CART with 10-fold cross validation will be used for building the final prediction model and determine the diagnostic cut point(s). CART analysis will also include demographics, comorbidity information, and relevant biological variables including sex. The final model accuracy will be assessed using AUC when fitting a ROC curve using predicted outcome against the actual outcome.
Model-free initial area under the contrast agent concentration curve (iAUC)
Time frame: Up to 3 years
The raw data will be acquired at the voxel level. Then the analytic parameters will be extracted from voxel-wise data such as the mean, median, interquartile range, skewness and kurtosis. ROC will be used to illustrate the univariate prediction accuracy for each parameter in predicting the clinically determined outcome. The pattern of change with different clinical response status will be visually illustrated using spaghetti plots or other graphical approaches. CART with 10-fold cross validation will be used for building the final prediction model and determine the diagnostic cut point(s). CART analysis will also include demographics, comorbidity information, and relevant biological variables including sex. The final model accuracy will be assessed using AUC when fitting a ROC curve using predicted outcome against the actual outcome.
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Related trials for Brain Metastases
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
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.
Krishna Nayak, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Bevacizumab Injection in people with Brain Metastases and Glioma of Brain, run by University of Southern California at 1 site 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
Volume transfer constant (Ktrans) (time frame: Up to 3 years). 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 5 Aug 2025.