Using advanced MRI to improve brain tumor biopsy targeting
Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
This study is testing if advanced MRI scans can help doctors take more accurate needle biopsies of brain tumors for people who have suspected or confirmed tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03458676 on ClinicalTrials.gov |
What this trial studies
This clinical research focuses on evaluating whether advanced magnetic resonance imaging (AMRI) can enhance the precision of needle biopsies for brain tumors compared to standard techniques. Participants with suspected or confirmed brain tumors will undergo AMRI scans, which include perfusion, diffusion, and spectroscopy imaging, to identify the most aggressive tumor areas. The information gathered from these scans will guide neurosurgeons during the biopsy procedure. The study aims to correlate the imaging results with biopsy outcomes to refine the use of AMRI in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a suspected or confirmed primary brain tumor who are scheduled for surgical resection.
Not a fit: Patients with unfavorable anatomical conditions for biopsy or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate biopsies, improving diagnosis and treatment planning for brain tumor patients.
How similar studies have performed: While the use of advanced imaging techniques in biopsy targeting is promising, this specific application of AMRI is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor. 3. Patient is able to understand and give consent to participation in the study. 4. 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. Exclusion Criteria: 1. The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed. 2. 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. 3. 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).
Where this trial is running
Houston, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dawid Schellingerhout, MD — M.D. Anderson Cancer Center
- Study coordinator: Dawid Schellingerhout, MD
- Email: dawid.schellingerhout@mdanderson.org
- Phone: 713-794-5673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.