Ultrasound Technique for Spinal Tap Assessment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new ultrasound technique to measure pressure inside the skull for individuals with conditions like idiopathic intracranial hypertension, which causes increased brain pressure. The technique uses tiny microbubbles (perflutren lipid microsphere, a type of contrast agent) and sound waves to estimate pressure without an invasive spinal tap. If successful, this could simplify and improve the safety of diagnosing and monitoring these conditions. Ideal participants have conditions requiring a spinal tap to check brain pressure and are not allergic to certain contrast agents. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this ultrasound technique is safe for spinal tap assessment?
Previous studies have safely used a substance called perflutren lipid microsphere to enhance ultrasound images. Research shows it works effectively and is generally safe for adults, including older adults. Most side effects are mild, such as headaches or nausea, and serious issues are rare. Thus, the treatment is considered safe for people.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new ultrasound technique for assessing spinal fluid pressure, potentially improving the accuracy of diagnosing conditions related to intracranial pressure (ICP). Unlike traditional spinal taps, which can be invasive and uncomfortable, this method uses perflutren lipid microsphere as a contrast agent, making the procedure less invasive and possibly safer. This innovation could lead to quicker, more precise diagnostics, sparing patients the discomfort and risks associated with traditional lumbar punctures.
What evidence suggests that the SHAPE technique is effective for monitoring intracranial pressure?
Research has shown that the SHAPE technique, which participants in this trial will experience, uses tiny bubbles called perflutren lipid microspheres and holds promise for measuring pressure inside the skull. This method employs ultrasound to activate these bubbles, enhancing image quality. Studies have found that it can estimate pressures in various body parts, such as the heart and other tissues, by observing bubble behavior. The bubbles help create clear images sensitive to pressure changes, crucial for diagnosing conditions like idiopathic intracranial hypertension, which involves high pressure around the brain. This technique could provide a noninvasive way to monitor brain pressure, potentially leading to better patient outcomes.678910
Are You a Good Fit for This Trial?
This trial is for adults over the age of 18 who are scheduled to undergo a lumbar puncture, commonly known as a spinal tap, to measure intracranial pressure (ICP).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo noninvasive ultrasound-based imaging using the SHAPE technique to estimate intracranial pressure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Perflutren lipid microsphere
Trial Overview
The SHAPE technique using Perflutren lipid microsphere contrast agents in ultrasound imaging is being tested as a noninvasive method to estimate ICP. This could be an alternative to direct measurement methods like lumbar punctures.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor
Mayo Clinic
Collaborator
Published Research Related to This Trial
Citations
Ultrasound Technique for Spinal Tap Assessment
Perflutren lipid microsphere is unique because it uses ultrasound to activate tiny bubbles that can enhance imaging and potentially improve the precision of ...
2.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06571786?term=AREA%5BBasicSearch%5D(lantheus)&rank=4Study Details | NCT06571786 | SHAPE for ICP Assessment
Drug : Perflutren lipid microsphere. Definity ( Lantheus Medical Imaging, N ... data with pressures obtained using lumbar puncture (reference standard) ...
Annual Meeting of the American Society of Neuroimaging
Methods: The echocardiographers have turned to Definity, an injectable suspension of perflutren lipid microspheres to increase the image quality ...
Sonothrombolysis: State-of-the-Art and Potential Applications ...
Infarct volume percent was lower for rabbits treated with lipid MB + US, 3 μm MB + US, and tagged 3 μm MB + US compared with controls. Microbubble groups had ...
5.
researchgate.net
researchgate.net/publication/391547652_Perflutren_lipid_microspheres_for_echocardiogram_contrast_a_clinical_case_of_anaphylaxis_not_caused_by_PEGPerflutren lipid microspheres for echocardiogram contrast
Background Perflutren lipid microsphere suspension, sold under the brand name Definity®, is a microbubble ultrasound contrast agent.
Perflutren: Uses, Interactions, Mechanism of Action
Perflutren, a diagnostic drug that is intended to be used for contrast enhancement during the indicated echocardiographic procedures, comprised of lipid-coated ...
7.
mayoclinic.org
mayoclinic.org/drugs-supplements/perflutren-lipid-microsphere-intravenous-route/description/drg-20067608Perflutren lipid microsphere (intravenous route)
Safety and efficacy have been established. Geriatric. Appropriate studies performed to date have not demonstrated geriatric-specific problems ...
Definity - accessdata.fda.gov
After activation, each vial contains a maximum of 1.2 X 1010 perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) octafluoropropane [see ...
Perflutren Uses, Side Effects & Warnings
Perflutren is an ultrasound contrast agent that is used to improve the quality of an echocardiogram (ultrasound of the heart).
Safety of Lumbar Puncture Performed on Dual Antiplatelet ...
Performing LPs in the setting of dual antiplatelet therapy may not pose an increased risk of serious complications.
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