Advanced MRI-Guided Biopsy for Brain Cancer

Overseen By Dawid Schellingerhout

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Unfavorable anatomy, Pacemakers, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any implants or devices that are not safe for MRI, you may not be eligible to participate.

Is the advanced MRI-guided biopsy for brain cancer safe?

Research shows that advanced MRI-guided biopsies, including frameless stereotactic techniques, are generally safe for humans. Studies found no major complications and confirmed the accuracy of the procedure, with the ability to correct any issues during surgery, making it a reliable and safe option for brain biopsies. ^{1 2 3 4 5}

How is the Advanced MRI-Guided Biopsy treatment for brain cancer different from other treatments?

This treatment is unique because it uses advanced MRI technology to guide the biopsy and tumor removal process, allowing for more precise targeting of brain tumors without the need for a traditional frame-based system. This can improve safety and accuracy compared to older methods. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Advanced MRI-Guided Biopsy for Brain Cancer?

Research shows that MRI-guided brain biopsies have a high diagnostic success rate, with one study reporting a 100% diagnostic yield, which is higher than traditional stereotactic methods. This suggests that using advanced MRI techniques can improve the accuracy and safety of brain biopsies. ^{6 7 8 10 11}

Who Is on the Research Team?

Dawid Schellingerhout

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with suspected or confirmed primary brain tumors who need a tumor resection. They must understand and consent to the study, have an MRI before surgery, and have adequate kidney function. It's not for those with MR-unsafe implants/devices, prior brain tumor treatments (except biopsy), claustrophobia unmanageable by medication, or certain non-CNS malignancies.

Inclusion Criteria

I am eligible for surgery to remove a brain tumor.

I agree to have an MRI with specific tests before my procedure.

My kidney function is good or moderately reduced, and I may need a special contrast for scans.

Exclusion Criteria

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, metallic splinters in the eye, ferromagnetic hemostatic clips in the central nervous system (CNS) or body, cochlear implants, other pacemakers, 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

I had treatment for a brain tumor but no brain cancer spread from other parts.

My anatomy makes it unsafe to perform a stereotactic biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

AMRI Scan

Participants undergo an advanced MRI scan to improve targeting of brain tumor needle biopsies

Less than 1 hour

1 visit (in-person)

Surgery and Biopsy

During surgery, neurosurgeons use AMRI information to decide biopsy locations. Biopsies are taken before tumor removal.

During surgery

Follow-up

Participants continue standard of care follow-up appointments in the neurosurgery clinic

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Magnetic Resonance Imaging Scan
• Standard of Care Brain Biopsy and Tumor Removal

Trial Overview The study tests if advanced magnetic resonance imaging (AMRI) can better target needle biopsies of brain tumors than standard methods. Researchers will compare image results with biopsy findings to improve AMRI use in diagnosis. The perfusion scan used is investigational and only for research purposes.

How Is the Trial Designed?

Group I: Advanced MR Imaging (AMRI) Scan Experimental Treatment 2 Interventions

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.

Advanced Magnetic Resonance Imaging Scan is already approved in United States for the following indications:

Approved in United States as Advanced MRI for:

• Research Use Only

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Intraoperative MRI-guided needle brain biopsy has a comparable diagnostic yield to traditional frame-based and frameless stereotactic methods, with positive diagnostic rates of 96.9%, 91.8%, and 89.9% respectively for patients without prior treatments.

This technique is associated with fewer serious adverse events and results in shorter postoperative hospital stays, making it a safer option for brain biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of frame-based, frameless, and intraoperative magnetic resonance imaging-guided brain biopsy techniques. Lu, Y., Yeung, C., Radmanesh, A., et al.[2022]

In a study of 43 patients with astrocytic brain tumors, MRI-guided stereotactic biopsies accurately diagnosed glioma grades in 79% of cases when followed by resection within 60 days, leading to correct treatment in 96% of instances.

The study found that non-enhancing lesions on MRI had a 100% correlation with subsequent histology, while enhancing lesions had a significantly lower correlation (61%), suggesting that enhancement may indicate a negative prognostic factor for biopsy accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided stereotactic biopsy in the diagnosis of glioma: comparison of biopsy and surgical resection specimen. McGirt, MJ., Villavicencio, AT., Bulsara, KR., et al.[2019]

In a study involving 28 patients, a new MR-guided biopsy technique using frameless stereotaxic guidance successfully retrieved diagnostic tissue in 25 cases, demonstrating high efficacy.

The technique showed a maximum spatial error of only 3.1 mm near the isocenter, indicating that it is both safe and accurate for performing biopsies and potentially for MR-guided therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive MR-guided biopsy in an open-configuration MR imaging system. Silverman, SG., Collick, BD., Figueira, MR., et al.[2004]

Interventional MR-guided brain biopsies demonstrated a 100% diagnostic yield in 35 procedures, compared to a 96% yield in 134 stereotactic biopsies, suggesting that MR guidance may enhance diagnostic accuracy.

Both techniques had similar safety profiles, with morbidity and mortality rates of 0.7% for stereotactic biopsies and a slightly higher transient hemiparesis rate of 3% for MR-guided biopsies, indicating that MR-guided biopsies are a safe alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of stereotactic brain biopsy to interventional magnetic-resonance-imaging-guided brain biopsy. Hall, WA., Liu, H., Martin, AJ., et al.[2018]

The study demonstrated that frameless stereotaxy combined with high-field intraoperative MRI and neuronavigation achieved a mean registration error of only 1.2 mm, allowing for precise placement of instruments in brain biopsies and catheter placements.

There were no neurological deficits or deaths related to the procedures, indicating a high safety profile, although there were two cases of wound infection, highlighting the need for careful postoperative monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frameless stereotactic surgery using intraoperative high-field magnetic resonance imaging. Nimsky, C., Fujita, A., Ganslandt, O., et al.[2019]

In a study of 15 patients undergoing frameless stereotactic iMRI-guided biopsies, the procedure was found to be safe with no major complications reported, and it allowed for accurate histopathological diagnoses of various brain tumors.

The average preparation and operation times were manageable (53 and 69 minutes, respectively), and the use of iMRI significantly enhanced the diagnostic value of the biopsies, suggesting it could improve both safety and economic efficiency in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative magnetic resonance-guided frameless stereotactic biopsies - initial clinical experience. Czyż, M., Tabakow, P., Jarmundowicz, W., et al.[2019]

Frameless stereotactic brain biopsy has a high diagnostic yield of 87.6% and is considered safe, with symptomatic postoperative complications occurring in only 1 out of 89 procedures.

The size of the brain lesion significantly impacts both the diagnostic yield and the risk of complications, with lesions larger than 3 cm yielding more positive biopsy results and smaller lesions being associated with higher rates of postoperative hematoma complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Yield and Complication of Frameless Stereotactic Brain Biopsy. Taweesomboonyat, C., Tunthanathip, T., Sae-Heng, S., et al.[2022]

In a study of 42 brain tumor patients, stereotactic brain tumor biopsy guided by low-field intraoperative MRI (iMRI) showed no major postoperative complications and had a diagnostic yield comparable to the traditional frameless biopsy method.

While the iMRI procedure took longer on average (111 minutes) compared to the frameless method (78 minutes), it was found to be equally safe and effective, suggesting that iMRI can be a viable option for guiding brain tumor biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and effectiveness of low field intraoperative MRI guidance in frameless stereotactic biopsies of brain tumours-design and interim analysis of a prospective randomized trial. Czyż, M., Tabakow, P., Weiser, A., et al.[2021]

Intraoperative MRI (iMRI) enhances the accuracy of brain biopsies by allowing real-time adjustments to the cannula trajectory, which helps prevent misdiagnosis from incorrect targeting.

This technology enables a minimally invasive percutaneous approach, reducing the need for large incisions and potentially decreasing operating room time and unnecessary tissue sampling, thereby improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Biopsy Platforms with Intraoperative Imaging Guidance. Mohyeldin, A., Elder, JB.[2022]

The use of intraoperative magnetic resonance imaging (iMRI) and multimodal navigation in brain biopsies resulted in a high diagnostic rate of 96.8% and allowed for the correction of 4.5% of incorrect biopsy sites, ensuring accuracy in targeting lesions.

This technique was found to be safe, as there were no significant changes in neurological status post-surgery, even with 55.1% of lesions located near critical brain areas, and it effectively identified and managed intraoperative complications like hematomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Implementation of multimodal navigation combined with intraoperative magnetic resonance imaging in the frameless stereotactic biopsy of intracranial lesions]. Zhang, JS., Chen, XL., Wang, Q., et al.[2019]

MRI-guided biopsy was successfully performed on a challenging suprasellar lesion in a 38-year-old woman, highlighting its potential as a safe and effective diagnostic tool for difficult-to-access brain areas.

The use of intraoperative MRI allowed for real-time adjustments during the procedure, which contributed to the accurate diagnosis of Langerhans cell histiocytosis and subsequent effective treatment with cladribine, leading to lesion regression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Magnetic Resonance Imaging-Guided Biopsy in the Diagnosis of Suprasellar Langerhans Cell Histiocytosis. Carroll, KT., Lochte, BC., Chen, JY., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of frame-based, frameless, and intraoperative magnetic resonance imaging-guided brain biopsy techniques. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

MRI-guided stereotactic biopsy in the diagnosis of glioma: comparison of biopsy and surgical resection specimen. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Interactive MR-guided biopsy in an open-configuration MR imaging system. [2004]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of stereotactic brain biopsy to interventional magnetic-resonance-imaging-guided brain biopsy. [2018]

5. Japan pubmed.ncbi.nlm.nih.gov

Frameless stereotactic surgery using intraoperative high-field magnetic resonance imaging. [2019]

6. Poland pubmed.ncbi.nlm.nih.gov

Intraoperative magnetic resonance-guided frameless stereotactic biopsies - initial clinical experience. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Yield and Complication of Frameless Stereotactic Brain Biopsy. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

The safety and effectiveness of low field intraoperative MRI guidance in frameless stereotactic biopsies of brain tumours-design and interim analysis of a prospective randomized trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Biopsy Platforms with Intraoperative Imaging Guidance. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[Implementation of multimodal navigation combined with intraoperative magnetic resonance imaging in the frameless stereotactic biopsy of intracranial lesions]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Magnetic Resonance Imaging-Guided Biopsy in the Diagnosis of Suprasellar Langerhans Cell Histiocytosis. [2018]