Malignant Brain NeoplasmNCT07339085
Advanced Magnetic Resonance Imaging for the Identification of Recurrent Brain Tumors and Radiation Necrosis
A study testing Advanced Magnetic Resonance Imaging, Biospecimen Collection and Magnetic Resonance Imaging in people with Malignant Brain Neoplasm and Metastatic Malignant Neoplasm in the Brain, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies whether advanced magnetic resonance imaging (MRI) techniques, including diffusion-relaxation correlation spectrum imaging (DR-CSI) and sodium imaging, can be used to identify the difference between brain tumors that come back after a period of improvement (recurrent) and treatment-related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Advanced Magnetic Resonance Imaging, Biospecimen Collection and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2025to 30 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age > 18 years old
- Diagnosed with metastatic brain tumor
- AIM 1: Scheduled for surgical resection or tissue biopsy +/- laser interstitial thermal therapy (LITT)
- AIM 2: Scheduled for SRS treatment
Who cannot join
- Patients with contraindications to MRI, severe renal impairment
- Patients with evidence of disseminated leptomeningeal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Jingwen Yao, 310-869-2156, JINGWENYAO@MEDNET.UCLA.EDU
Jingwen Yao
About this study
Official title: Advanced Dual-Nuclei MRI for Differentiation of Recurrent Brain Metastases and Radiation Necrosis
This clinical trial studies whether advanced magnetic resonance imaging (MRI) techniques, including diffusion-relaxation correlation spectrum imaging (DR-CSI) and sodium imaging, can be used to identify the difference between brain tumors that come back after a period of improvement (recurrent) and treatment-related tissue damage (radiation necrosis [RN]). Radiation therapy is often used in the treatment of brain tumors. Radiation treatment response can be difficult to assess and is usually done using conventional MRI, which uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Current imaging techniques have a limited ability to identify the difference between recurrent brain tumor and RN due to their similar appearance on conventional MRI and overlapping clinical presentation. This makes it hard for doctors to plan the best way to treat these tumors. DR-CSI is a new MRI technique with the potential to detect microscopic tissue components with different characteristics. Sodium imaging is an MRI technique that estimates the total sodium concentration in the obtained images. It may be able to identify the small structures within the tissue of brain tumors. Advanced MRI techniques like DR-CSI and sodium imaging may be effective in identifying the difference between recurrent brain tumors and RN.
Read the detailed description
PRIMARY OBJECTIVES:
- Develop and validate dual-nuclei microstructural MRI biomarkers to differentiate between recurrent brain metastasis (rBM) and RN.
II. Investigate longitudinal microstructural changes following stereotactic radiosurgery (SRS) treatment and predict clinical outcome.
OUTLINE: Patients are assigned to 1 of 2 aims.
AIM 1: Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to standard of care (SOC) surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study.
AIM 2: Patients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study.
- Being tested
- Advanced Magnetic Resonance Imaging, Biospecimen Collection, Magnetic Resonance Imaging
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Magnetic Resonance ImagingProcedure or surgery
Also called AMRI
Undergo advanced DR-CSI and sodium MRI
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo tissue sample collection
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo clinical MRI
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 (advanced MRI) | Experimental | Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to SOC surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study. Receives: Procedure: Advanced Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging |
| Aim 2 (advanced MRI) | Experimental | Patients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study. Receives: Procedure: Advanced Magnetic Resonance Imaging; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging features of recurrent brain metastasis (rBM) and radiation necrosis (RN) (Aim 1)
Will compute the diffusion-relaxation (DR) spectra and total sodium concentration (TSC) within biopsy regions of interest and use Student t-test or Mann-Whitney U test, depending on the data distribution, to compare imaging features between rBM and RN groups. Specifically, for DR spectra, the test statistic at each spectral location will be used to identify spectral components associated viable tumor and treatment effect. The information will subsequently be used to partition the voxel-wise DR spectra and compute voxel-wise "viable tumor" and "treatment effect" fraction maps. Multivariate logistic regression models will assess the predictive value of the imaging biomarkers, including DR-correlation spectrum imaging (CSI) spectral components and TSC. Receiver operating characteristic (ROC) analysis will evaluate diagnostic performance, calculating area under the curve, sensitivity, specificity, and optimal cutoff values for differentiating rBM and RN.
Measured: At time of advanced magnetic resonance imaging: Baseline
Stereotacic imaging-guided biopsies and correlation with tissue quantifications (Aim 1)
Will prospectively acquire DR-CSI and sodium imaging-guided biopsies of tumor tissue in regions with different imaging characteristics. Pearson or Spearman correlations will be computed between imaging features and quantitative histological measures of cellularity, extracellular fraction, and percentages of tumor and necrosis.
Measured: Up to completion of surgery
Early imaging changes as predictors of clinical outcomes (Aim 2)
Will compute DR-CSI spectral components and TSC at each time point. Repeated measure analysis of variance will assess imaging changes over time. Will also plot trajectories of imaging biomarkers to visualize temporal patterns. Multivariate logistic regression models will evaluate early imaging changes (2 weeks and 3 months) as predictors of 6-month outcomes. Lesions will be stratified into responders (complete or partial response) and non-responders (stable disease or progression) based on their Response Assessment in Neuro-Oncology Brain Metastases assessment at 6-month post-SRS. ROC curves will assess the predictive performance of early microstructural imaging changes and the multivariate model. Primary tumor type will be included as a covariate in analyses.
Measured: At baseline and 2 weeks, 3 months, and 6 months post-stereotactic radiosurgery (SRS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start28 Aug 2025
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jingwen Yao, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339085
- Sponsor's protocol ID
- 25-1250
- Other IDs
- NCI-2025-06605, 25-1250, P30CA016042, R21CA303383
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 15 Jan 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Dual-Nuclei MRI for Differentiation of Recurrent Brain Metastases and Radiation Necrosis
- ClinicalTrials.gov ID
- NCT07339085
- Acronym / sponsor ID
- 25-1250
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 14 Jan 2026 (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 clinical trial studies whether advanced magnetic resonance imaging (MRI) techniques, including diffusion-relaxation correlation spectrum imaging (DR-CSI) and sodium imaging, can be used to identify the difference between brain tumors that come back after a period of improvement (recurrent) and treatment-related tissue damage (radiation necrosis [RN]). Radiation therapy is often used in the treatment of brain tumors. Radiation treatment response can be difficult to assess and is usually done using conventional MRI, which uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Current imaging techniques have a limited ability to identify the difference between recurrent brain tumor and RN due to their similar appearance on conventional MRI and overlapping clinical presentation. This makes it hard for doctors to plan the best way to treat these tumors. DR-CSI is a new MRI technique with the potential to detect microscopic tissue components with different characteristics. Sodium imaging is an MRI technique that estimates the total sodium concentration in the obtained images. It may be able to identify the small structures within the tissue of brain tumors. Advanced MRI techniques like DR-CSI and sodium imaging may be effective in identifying the difference between recurrent brain tumors and RN.
Detailed description
PRIMARY OBJECTIVES:
- Develop and validate dual-nuclei microstructural MRI biomarkers to differentiate between recurrent brain metastasis (rBM) and RN.
II. Investigate longitudinal microstructural changes following stereotactic radiosurgery (SRS) treatment and predict clinical outcome.
OUTLINE: Patients are assigned to 1 of 2 aims.
AIM 1: Patients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to standard of care (SOC) surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study.
AIM 2: Patients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 (advanced MRI) | Experimental | Procedure: Advanced Magnetic Resonance Imaging, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance ImagingPatients undergo advanced DR-CSI and sodium MRI over 30 minutes prior to SOC surgical resection or biopsy. Patients also undergo clinical MRI and tissue sample collection on study. |
| Aim 2 (advanced MRI) | Experimental | Procedure: Advanced Magnetic Resonance Imaging, Procedure: Magnetic Resonance ImagingPatients undergo advanced DR-CSI and sodium MRI over 30 minutes before SRS and 2 weeks, 3 months, and 6 months post-SRS. Patients also undergo clinical MRI on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Diagnosed with metastatic brain tumor
- AIM 1: Scheduled for surgical resection or tissue biopsy +/- laser interstitial thermal therapy (LITT)
- AIM 2: Scheduled for SRS treatment
Key exclusion criteria (2 listed)
- Patients with contraindications to MRI, severe renal impairment
- Patients with evidence of disseminated leptomeningeal disease
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 |
|---|---|---|
| Advanced Magnetic Resonance ImagingAlso: AMRIUndergo advanced DR-CSI and sodium MRI | Procedure or surgery | Aim 1 (advanced MRI), Aim 2 (advanced MRI) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo tissue sample collection | Procedure or surgery | Aim 1 (advanced MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo clinical MRI | Procedure or surgery | Aim 1 (advanced MRI), Aim 2 (advanced MRI) |
Primary outcome
Imaging features of recurrent brain metastasis (rBM) and radiation necrosis (RN) (Aim 1)
Time frame: At time of advanced magnetic resonance imaging: Baseline
Will compute the diffusion-relaxation (DR) spectra and total sodium concentration (TSC) within biopsy regions of interest and use Student t-test or Mann-Whitney U test, depending on the data distribution, to compare imaging features between rBM and RN groups. Specifically, for DR spectra, the test statistic at each spectral location will be used to identify spectral components associated viable tumor and treatment effect. The information will subsequently be used to partition the voxel-wise DR spectra and compute voxel-wise "viable tumor" and "treatment effect" fraction maps. Multivariate logistic regression models will assess the predictive value of the imaging biomarkers, including DR-correlation spectrum imaging (CSI) spectral components and TSC. Receiver operating characteristic (ROC) analysis will evaluate diagnostic performance, calculating area under the curve, sensitivity, specificity, and optimal cutoff values for differentiating rBM and RN.
Stereotacic imaging-guided biopsies and correlation with tissue quantifications (Aim 1)
Time frame: Up to completion of surgery
Will prospectively acquire DR-CSI and sodium imaging-guided biopsies of tumor tissue in regions with different imaging characteristics. Pearson or Spearman correlations will be computed between imaging features and quantitative histological measures of cellularity, extracellular fraction, and percentages of tumor and necrosis.
Early imaging changes as predictors of clinical outcomes (Aim 2)
Time frame: At baseline and 2 weeks, 3 months, and 6 months post-stereotactic radiosurgery (SRS)
Will compute DR-CSI spectral components and TSC at each time point. Repeated measure analysis of variance will assess imaging changes over time. Will also plot trajectories of imaging biomarkers to visualize temporal patterns. Multivariate logistic regression models will evaluate early imaging changes (2 weeks and 3 months) as predictors of 6-month outcomes. Lesions will be stratified into responders (complete or partial response) and non-responders (stable disease or progression) based on their Response Assessment in Neuro-Oncology Brain Metastases assessment at 6-month post-SRS. ROC curves will assess the predictive performance of early microstructural imaging changes and the multivariate model. Primary tumor type will be included as a covariate in analyses.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 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.
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, United States
Jingwen Yao principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Magnetic Resonance Imaging, Biospecimen Collection and Magnetic Resonance Imaging in people with Malignant Brain Neoplasm and Metastatic Malignant Neoplasm in the Brain, run by Jonsson Comprehensive Cancer Center 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging features of recurrent brain metastasis (rBM) and radiation necrosis (RN) (Aim 1) (time frame: At time of advanced magnetic resonance imaging: Baseline). The study lists 3 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 15 Jan 2026.