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NCT06571786 · ClinicalTrials.gov registry record · Phase 2

SHAPE for ICP Assessment

A Phase 2 study, sponsored by Thomas Jefferson University.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target

NCT06571786 is a Phase 2 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 19 participants.

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The verdict

NCT06571786, a Phase 2 study, has completed, sponsored by Thomas Jefferson University.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study 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.

Interventions

  • DRUG Perflutren lipid microsphere

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2024-12-15
Est. Completion 2025-08-26
Phase Phase 2

Sponsor

Thomas Jefferson University

292 total trials

What the Registry Record Tells You About NCT06571786

The ClinicalTrials.gov registry entry for NCT06571786 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Perflutren lipid microsphere is the first listed.

NCT06571786 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06571786 about?

NCT06571786 is a clinical study titled "SHAPE for ICP Assessment". 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 lipi...

What is the current status of trial NCT06571786?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2024-12-15. Estimated completion is 2025-08-26.

What interventions are being tested in trial NCT06571786?

The interventions under investigation include: Perflutren lipid microsphere (DRUG).

Who is sponsoring clinical trial NCT06571786?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.