SHAPE for ICP Assessment

NCT06571786 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2023-2116
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Lumbar Puncture

Outcome Measures

Primary Outcomes (1)

• Comparing SHAPE to lumbar puncture pressure measurements

  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)

  1 year

Study Arms (1)

SHAPE for ICP diagnosis

EXPERIMENTAL

Drug: Perflutren lipid microsphere

Interventions

Perflutren lipid microsphere DRUG

Definity (Lantheus Medical Imaging, N Billerica, MA) in 25 mL of saline infused for up to 6 minutes

Also known as: Definity

SHAPE for ICP diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Mayo Clinic: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

perflutren

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: December 15, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 26, 2025
• Last Updated: September 4, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: 12 months after completion of the study

Locations

US (2)