Brain LesionNCT03458676
Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
A study testing Advanced Magnetic Resonance Imaging Scan in people with Brain Lesion, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if using advanced magnetic resonance imaging (AMRI) will improve the targeting of brain tumor needle biopsies compared to the standard targeting techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Lesion
- What is being tested?
- Advanced Magnetic Resonance Imaging Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2012to 1 Sep 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
- Patient is >18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.
- Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.
- Patient is able to understand and give consent to participation in the study.
- Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging. As per study chair's judgement, imaging outside this time window will also be permitted, for suspected slow growing tumors.
Who cannot join
- The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.
- Renal failure as evidenced by a GFR of less than 30 mL/min/1.73m2 for gadolinium based imaging, for iodinated contrast agent we will use the more strict cut-off of 45 mL/min/1.73m2 (Davenport, 2020, Radiology: Use of IV Iodinated contrast media in patients with Kidney Disease: Consensus statement from the ACR and the National Kidney Foundation). This differentiation reflects the different risk profiles of these agents, and are conservative when compared to our clinical practice. In the absence of eGFR lab result, patient is not excluded in the absence of remarkable pathological renal history as confirmed by and in the discretion of the PI. As per current departmental guidelines, late-generation gadolinium contrast agents (such as gadobutrol and gadopiclenol), can still be administered safely in the setting of low renal function, provided clinical risk-benefit is maintained.
- Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:
- electronically, magnetically, and mechanically activated implants
- ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
- metallic splinters in the eye
Show all 15Show fewer
- ferromagnetic hemostatic clips in the central nervous system (CNS) or body
- cochlear implants
- other pacemakers, e.g., for the carotid sinus
- insulin pumps and nerve stimulators
- non-MR safe lead wires
- prosthetic heart valves (if dehiscence is suspected)
- non-ferromagnetic stapedial implants
- pregnancy
- claustrophobia that does not readily respond to oral medication 4. Allergy to relevant imaging contrast agents, includes allergies to iodine or gadolinium-based contrast agents (if one class of agents is contra-indicated, then imaging with the other can still proceed).
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
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Dawid Schellingerhout, MD, dawid.schellingerhout@mdanderson.org
About this study
The goal of this clinical research study is to learn if using advanced magnetic resonance imaging (AMRI) will improve the targeting of brain tumor needle biopsies compared to the standard targeting techniques. Researchers also want to learn how the results of the images and biopsies compare to each other to try to improve the way researchers and radiologists use AMRI images.
This is an investigational study. The perfusion scan is not FDA approved or commercially available. It is currently only being used in research.
Read more
There will be no cost to you for the advanced MRI, additional anesthesia, special pathology stains, and/or gene testing for this study.
Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.
Read the detailed description
Participant is being asked to take part in this study because participant has a lesion in participant's brain which is suspected or proven to be a tumor and participant has been scheduled for surgery to remove it.
Some parts of brain tumors are more aggressive than other parts. A needle biopsy only gets a small part of the brain tumor cells. Doctors (neurosurgeons) want to get a biopsy sample from the most aggressive part of the tumor. Researchers think that AMRI techniques may help to better target the most aggressive part of the tumor for the needle biopsy.
AMRI Scan:
In addition to the images that will be taken as part of participant's standard of care surgery preparation, participant will have an AMRI scan performed. The AMRI has several parts. There are 2 perfusion scans that use a contrast dye to look at small blood vessels. There is a spectroscopy scan to looks at the chemical make-up of the tumor. There is also a diffusion scan to look at how water moves in the tumor and can see the white matter that connects both sides of brain parts. The AMRI scans are performed in the same way as normal MRI scans and in the same scanner. They can be noisy, but do not feel any different than standard MRI exams.
In most cases, the AMRI should take less than 1 hour to complete and will be performed within 2 weeks before participant's standard of care surgery.
Surgery During the surgery, the neurosurgeon(s) will use the information collected from the AMRI to decide what area of the brain tumor will be biopsied. The biopsies are only from areas that would normally be cut out during surgery and will not change the way the surgery is done even if participant chooses not to take part in this study. Biopsies (from up to 5 locations, each smaller than participant's thumbnail) will be taken before the tumor is surgically removed. The tumor tissue samples from the biopsies will be tested to learn more about the tumor and optionally the DNA inside(the genetic material of cells - this procedure is described in the optional procedures section below).
After the surgery is over, participant will continue to have participant's standard of care follow-up appointments in the neurosurgery clinic.
Length of Study After the biopsy is complete, your active participation on this study will be over. Participant's medical records will continue to be reviewed for up to an additional 5 years.
Follow-Up Medical Record Review:
After participant's active participation on this study is over, participant's medical record will be reviewed to learn how participant is doing, what other treatments participant may have had and how they worked, if participant had any new brain problems or if the tumor came back. Researchers will review and record information from participant's medical records for up to 5 years after participant's active participation on this study is over.
- Conditions
- Brain Lesion
- Being tested
- Advanced Magnetic Resonance Imaging Scan, Standard of Care Brain Biopsy and Tumor Removal
- Keywords
- Advanced magnetic resonance imaging, AMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Magnetic Resonance Imaging ScanProcedure or surgery
Also called AMRI
AMRI scan performed within 2 weeks before standard of care brain biopsy and tumor removal surgery.
AMRI scan should take less than 1 hour to complete
Standard of Care Brain Biopsy and Tumor RemovalProcedure or surgery
During the surgery, the neurosurgeon(s) uses the information collected from the AMRI to decide what area of the brain tumor will be biopsied.
Biopsies from up to 5 locations taken before the tumor is surgically removed.
| Study group | Role | What they receive |
|---|---|---|
| Advanced MR Imaging (AMRI) Scan | Experimental | AMRI scan performed within 2 weeks before standard of care brain surgery.
During the surgery, neurosurgeon(s) use the information collected from the AMRI to decide what area of the brain tumor will be biopsied. Receives: Procedure: Advanced Magnetic Resonance Imaging Scan; Procedure: Standard of Care Brain Biopsy and Tumor Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Accuracy of the Pathological Grades of Tumor Observed at the Biopsy Locations Identified Using Conventional Versus Advanced Imaging
Researchers wish to determine if the accuracy of the pathological grade observed at the biopsy sites identified by advanced imaging is higher than the grades observed at the biopsy sites identified by conventional imaging.
Measured: 2 weeks
Target Sample Grading
The quantitative pathology markers compared between the conventional and advanced target specimens.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start6 Sep 2012
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain LesionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawid Schellingerhout, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458676
- Sponsor's protocol ID
- 2011-0370
- Other IDs
- NCI-2018-00924
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2018
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
- ClinicalTrials.gov ID
- NCT03458676
- Acronym / sponsor ID
- 2011-0370
- Conditions
- Brain Lesion
- Keywords
- Advanced magnetic resonance imaging, AMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Sep 2012 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 8 Mar 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.
The goal of this clinical research study is to learn if using advanced magnetic resonance imaging (AMRI) will improve the targeting of brain tumor needle biopsies compared to the standard targeting techniques. Researchers also want to learn how the results of the images and biopsies compare to each other to try to improve the way researchers and radiologists use AMRI images.
This is an investigational study. The perfusion scan is not FDA approved or commercially available. It is currently only being used in research.
There will be no cost to you for the advanced MRI, additional anesthesia, special pathology stains, and/or gene testing for this study.
Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.
Detailed description
Participant is being asked to take part in this study because participant has a lesion in participant's brain which is suspected or proven to be a tumor and participant has been scheduled for surgery to remove it.
Some parts of brain tumors are more aggressive than other parts. A needle biopsy only gets a small part of the brain tumor cells. Doctors (neurosurgeons) want to get a biopsy sample from the most aggressive part of the tumor. Researchers think that AMRI techniques may help to better target the most aggressive part of the tumor for the needle biopsy.
AMRI Scan:
In addition to the images that will be taken as part of participant's standard of care surgery preparation, participant will have an AMRI scan performed. The AMRI has several parts. There are 2 perfusion scans that use a contrast dye to look at small blood vessels. There is a spectroscopy scan to looks at the chemical make-up of the tumor. There is also a diffusion scan to look at how water moves in the tumor and can see the white matter that connects both sides of brain parts. The AMRI scans are performed in the same way as normal MRI scans and in the same scanner. They can be noisy, but do not feel any different than standard MRI exams.
In most cases, the AMRI should take less than 1 hour to complete and will be performed within 2 weeks before participant's standard of care surgery.
Surgery During the surgery, the neurosurgeon(s) will use the information collected from the AMRI to decide what area of the brain tumor will be biopsied. The biopsies are only from areas that would normally be cut out during surgery and will not change the way the surgery is done even if participant chooses not to take part in this study. Biopsies (from up to 5 locations, each smaller than participant's thumbnail) will be taken before the tumor is surgically removed. The tumor tissue samples from the biopsies will be tested to learn more about the tumor and optionally the DNA inside(the genetic material of cells - this procedure is described in the optional procedures section below).
After the surgery is over, participant will continue to have participant's standard of care follow-up appointments in the neurosurgery clinic.
Length of Study After the biopsy is complete, your active participation on this study will be over. Participant's medical records will continue to be reviewed for up to an additional 5 years.
Follow-Up Medical Record Review:
After participant's active participation on this study is over, participant's medical record will be reviewed to learn how participant is doing, what other treatments participant may have had and how they worked, if participant had any new brain problems or if the tumor came back. Researchers will review and record information from participant's medical records for up to 5 years after participant's active participation on this study is over.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced MR Imaging (AMRI) Scan | Experimental | Procedure: Advanced Magnetic Resonance Imaging Scan, Procedure: Standard of Care Brain Biopsy and Tumor RemovalAMRI scan performed within 2 weeks before standard of care brain surgery. During the surgery, neurosurgeon(s) use the information collected from the AMRI to decide what area of the brain tumor will be biopsied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is >18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.
- Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.
- Patient is able to understand and give consent to participation in the study.
- Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging. As per study chair's judgement, imaging outside this time window will also be permitted, for suspected slow growing tumors.
Key exclusion criteria (15 listed)
- The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.
- Renal failure as evidenced by a GFR of less than 30 mL/min/1.73m2 for gadolinium based imaging, for iodinated contrast agent we will use the more strict cut-off of 45 mL/min/1.73m2 (Davenport, 2020, Radiology: Use of IV Iodinated contrast media in patients with Kidney Disease: Consensus statement from the ACR and the National Kidney Foundation). This differentiation reflects the different risk profiles of these agents, and are conservative when compared to our clinical practice. In the absence of eGFR lab result, patient is not excluded in the absence of remarkable pathological renal history as confirmed by and in the discretion of the PI. As per current departmental guidelines, late-generation gadolinium contrast agents (such as gadobutrol and gadopiclenol), can still be administered safely in the setting of low renal function, provided clinical risk-benefit is maintained.
- Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:
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 Imaging ScanAlso: AMRIAMRI scan performed within 2 weeks before standard of care brain biopsy and tumor removal surgery. AMRI scan should take less than 1 hour to complete | Procedure or surgery | Advanced MR Imaging (AMRI) Scan |
| Standard of Care Brain Biopsy and Tumor RemovalDuring the surgery, the neurosurgeon(s) uses the information collected from the AMRI to decide what area of the brain tumor will be biopsied. Biopsies from up to 5 locations taken before the tumor is surgically removed. | Procedure or surgery | Advanced MR Imaging (AMRI) Scan |
Primary outcome
Comparison of the Accuracy of the Pathological Grades of Tumor Observed at the Biopsy Locations Identified Using Conventional Versus Advanced Imaging
Time frame: 2 weeks
Researchers wish to determine if the accuracy of the pathological grade observed at the biopsy sites identified by advanced imaging is higher than the grades observed at the biopsy sites identified by conventional imaging.
Target Sample Grading
Time frame: 2 weeks
The quantitative pathology markers compared between the conventional and advanced target specimens.
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 6 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Dawid Schellingerhout, MD principal investigator
M.D. Anderson 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 Scan in people with Brain Lesion, run by M.D. Anderson 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 15 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 6 Oct 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?
Contact Dawid Schellingerhout, MD (713-794-5673, dawid.schellingerhout@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Accuracy of the Pathological Grades of Tumor Observed at the Biopsy Locations Identified Using Conventional Versus Advanced Imaging (time frame: 2 weeks). The study lists 2 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 6 Oct 2026.