BridgeMD
New treatment option for Brain Lesion
Official title Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
ClinicalTrials.gov ID: NCT03458676
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is \>18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population...
- 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...
You likely can't join if
- 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...
- Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not...
- electronically, magnetically, and mechanically activated implants
- ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
- metallic splinters in the eye
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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 like automatic cardioverter defibrillators and cardiac pacemakers
- metallic splinters in the eye
- ferromagnetic hemostatic clips in the central nervous system (CNS) or body
- cochlear implants
- other pacemakers, e.g., for the carotid sinus
- 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 4. Allergy to relevant imaging contrast agents, includes allergies to iodine or gadolinium-based contrast agents (if one class of agents is...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.