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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: Completed Phase 2 study, sponsored by Thomas Jefferson University.

NCT06571786 is a Phase 2 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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)

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
Thomas Jefferson University

292 total trials

What the finished NCT06571786 record still lists

NCT06571786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

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

NCT06571786 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06571786's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06571786, the US trial registry maintained by the National Library of Medicine. NCT06571786 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.