University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT03458676
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
Location status: Recruiting
Participant is being asked to take part in this study because participant has a lesion in participant's brain which is suspected or proven to be a tumor and participant has been scheduled for surgery to remove it.
Some parts of brain tumors are more aggressive than other parts. A needle biopsy only gets a small part of the brain tumor cells. Doctors (neurosurgeons) want to get a biopsy sample from the most aggressive part of the tumor. Researchers think that AMRI techniques may help to better target the most aggressive part of the tumor for the needle biopsy.
AMRI Scan:
In addition to the images that will be taken as part of participant's standard of care surgery preparation, participant will have an AMRI scan performed. The AMRI has several parts. There are 2 perfusion scans that use a contrast dye to look at small blood vessels. There is a spectroscopy scan to looks at the chemical make-up of the tumor. There is also a diffusion scan to look at how water moves in the tumor and can see the white matter that connects both sides of brain parts. The AMRI scans are performed in the same way as normal MRI scans and in the same scanner. They can be noisy, but do not feel any different than standard MRI exams.
In most cases, the AMRI should take less than 1 hour to complete and will be performed within 2 weeks before participant's standard of care surgery.
Surgery During the surgery, the neurosurgeon(s) will use the information collected from the AMRI to decide what area of the brain tumor will be biopsied. The biopsies are only from areas that would normally be cut out during surgery and will not change the way the surgery is done even if participant chooses not to take part in this study. Biopsies (from up to 5 locations, each smaller than participant's thumbnail) will be taken before the tumor is surgically removed. The tumor tissue samples from the biopsies will be tested to learn more about the tumor and optionally the DNA inside(the genetic material of cells - this procedure is described in the optional procedures section below).
After the surgery is over, participant will continue to have participant's standard of care follow-up appointments in the neurosurgery clinic.
Length of Study After the biopsy is complete, your active participation on this study will be over. Participant's medical records will continue to be reviewed for up to an additional 5 years.
Follow-Up Medical Record Review:
After participant's active participation on this study is over, participant's medical record will be reviewed to learn how participant is doing, what other treatments participant may have had and how they worked, if participant had any new brain problems or if the tumor came back. Researchers will review and record information from participant's medical records for up to 5 years after participant's active participation on this study is over.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: AMRI
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.
Time frame: 2 weeks
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
The quantitative pathology markers compared between the conventional and advanced target specimens.
Contact information is provided by the study sponsor or research team.
M.D. Anderson Cancer Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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