Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies

NCT03458676 | Recruiting

• 2 other identifiers: 2011-0370NCI-2018-00924
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Lesion

Keywords

Advanced magnetic resonance imaging; AMRI

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks

• Target Sample Grading

  The quantitative pathology markers compared between the conventional and advanced target specimens.

  2 weeks

Study Arms (1)

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.

Procedure: Advanced Magnetic Resonance Imaging Scan; Procedure: Standard of Care Brain Biopsy and Tumor Removal

Interventions

Advanced Magnetic Resonance Imaging Scan PROCEDURE

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

Also known as: AMRI

Advanced MR Imaging (AMRI) Scan

Standard of Care Brain Biopsy and Tumor Removal PROCEDURE

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.

Advanced MR Imaging (AMRI) Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Study Officials

• Dawid Schellingerhout, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawid Schellingerhout, MD

CONTACT

713-794-5673; dawid.schellingerhout@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: September 6, 2012
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)