Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | September 6, 2012 |
End Date: | September 2021 |
Contact: | Dawid Schellingerhout, MD |
Email: | CR_Study_Registration@mdanderson.org |
Phone: | 713-794-5673 |
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.
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.
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.
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.
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.
5. Patient has a GFR > 60. In patients with moderate renal failure (GFR 30-60), an
alternate injection with 2 times half-dose multihance (gadobenate dimeglumine) or
gadovist (gadobutrol) will be considered, if a contrast exam is deemed clinically
necessary.
Exclusion Criteria:
1. The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy
could not be safely performed.
2. 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
3. Prior brain tumor treatment, including surgical resection, radiation therapy or
chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the
patient from participation. Remote history (> 6month) of non-CNS malignancy in
remission, without evidence of current/ prior brain metastasis, will also not
disqualify patient from participating.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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