62 Participants Needed

Advanced MRI-Guided Biopsy for Brain Cancer

Dawid Schellingerhout | MD Anderson ...
Overseen ByDawid Schellingerhout
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.678910

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.123611

Research Team

Dawid Schellingerhout | MD Anderson ...

Dawid Schellingerhout

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.
See 2 more

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

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

Treatment Details

Interventions

  • Advanced Magnetic Resonance Imaging Scan
  • Standard of Care Brain Biopsy and Tumor Removal
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Advanced MR Imaging (AMRI) ScanExperimental Treatment2 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

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

References

Comparative effectiveness of frame-based, frameless, and intraoperative magnetic resonance imaging-guided brain biopsy techniques. [2022]
MRI-guided stereotactic biopsy in the diagnosis of glioma: comparison of biopsy and surgical resection specimen. [2019]
Interactive MR-guided biopsy in an open-configuration MR imaging system. [2004]
Comparison of stereotactic brain biopsy to interventional magnetic-resonance-imaging-guided brain biopsy. [2018]
Frameless stereotactic surgery using intraoperative high-field magnetic resonance imaging. [2019]
Intraoperative magnetic resonance-guided frameless stereotactic biopsies - initial clinical experience. [2019]
Diagnostic Yield and Complication of Frameless Stereotactic Brain Biopsy. [2022]
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]
Stereotactic Biopsy Platforms with Intraoperative Imaging Guidance. [2022]
[Implementation of multimodal navigation combined with intraoperative magnetic resonance imaging in the frameless stereotactic biopsy of intracranial lesions]. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Intraoperative Magnetic Resonance Imaging-Guided Biopsy in the Diagnosis of Suprasellar Langerhans Cell Histiocytosis. [2018]