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

ConditionBrain Lesion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

electronically, magnetically, and mechanically activated implants

ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers

Trial design

Design model

Single group

Treatments tested in this trial

  • Advanced Magnetic Resonance Imaging Scan

    Procedure/Surgery

    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 Removal

    Procedure/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.

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Advanced MR Imaging (AMRI) ScanExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 weeks
2

Target Sample Grading

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

Time frame
2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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