Skip to main content
Clinical Trials/NCT06571786
NCT06571786
Completed
Phase 2

Subharmonic Aided Pressure Estimation (SHAPE) for Intracranial Pressure (ICP) Assessment

Thomas Jefferson University2 sites in 1 country19 target enrollmentDecember 15, 2024

Overview

Phase
Phase 2
Intervention
Perflutren lipid microsphere
Conditions
Lumbar Puncture
Sponsor
Thomas Jefferson University
Enrollment
19
Locations
2
Primary Endpoint
Comparing SHAPE to lumbar puncture pressure measurements
Status
Completed
Last Updated
8 months ago

Overview

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 vasculature. When the contrast microbubbles are insonated with relatively high acoustic pressures (>100-150 kPa), these microbubbles act as nonlinear oscillators yielding energy components in the received echo signals at frequencies ranging from the subharmonic (half of transmit frequency) to higher harmonics and even ultraharmonics. Based on empirical evidence, the subharmonic signal exhibits a sigmoidal relationship with incident acoustic pressure i.e., subharmonic signal can be divided into occurrence, growth and saturation stages. In the growth stage, the subharmonic signal has shown sensitivity to ambient pressure characterized by an inverse linear relationship between subharmonic signal and ambient pressure changes. This inverse linear relationship forms the basis for the SHAPE technique. Several pre-clinical and clinical studies have been conducted to utilize the SHAPE technique for in vivo pressure estimation e.g., to diagnose portal hypertension, to estimate intra-cardiac pressures and to determine interstitial fluid pressures. The core imaging mode underpinning the SHAPE technology (subharmonic imaging) is now available on some commercial scanners. In the proposed pilot study, the SHAPE technique will be leveraged for monitoring intracranial pressure (ICP). The use of SHAPE technique for the ophthalmic artery could potentially provide an accurate noninvasive method of measuring ICP in patients with idiopathic intracranial hypertension (IIH) and other conditions of raised ICP, which would revolutionize the field.

Registry
clinicaltrials.gov
Start Date
December 15, 2024
End Date
August 26, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Flemming Forsberg

Professor

Thomas Jefferson University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

SHAPE for ICP diagnosis

Intervention: Perflutren lipid microsphere

Outcomes

Primary Outcomes

Comparing SHAPE to lumbar puncture pressure measurements

Time Frame: 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)

Study Sites (2)

Loading locations...

Similar Trials