SHAPE for ICP Assessment

Phase 2

Not yet recruiting

• Conditions: Lumbar Puncture
• Interventions: Drug: Perflutren lipid microsphere

• Registration Number: NCT06571786
• Lead Sponsor: Thomas Jefferson University

Brief Summary

The Subharmonic Aided Pressure Estimation (SHAPE) technique is a noninvasive ultrasound-based imaging technique that can estimate ambient pressure using subharmonic emissions from ultrasound contrast agents. Ultrasound contrast agents are encapsulated microbubbles (mean diameter \< 8 µm) with a lipid, protein, or polymer shell that traverse the entire vascul...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Start: 2024-09-23
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Scheduled for lumbar puncture to assess ICP pressures
• Age over 18.

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Exclusion Criteria

• Pregnant or nursing
• Medically unstable
• Allergy to any components of Definity.
• Unable to provide written informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHAPE for ICP diagnosis	Perflutren lipid microsphere	-

Primary Outcome Measures

Name	Time	Method
Comparing SHAPE to lumbar puncture pressure measurements	1 year	Use of the SHAPE technique for measuring ophthalmic artery pressure in patients undergoing lumbar puncture for suspected idiopathic intracranial hypertension and compare the SHAPE data with pressures obtained using lumbar puncture (reference standard)