NCT02398266

Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

Status unknown Phase 2 Last updated 19 June 2017

What this trial tests

Phase 2 trial testing Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging) in Peripheral Artery Disease in 55 participants. Status unknown.

Timeline

1 August 2016

Primary endpoint
1 July 2018

1 July 2018

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	55
Start date	1 August 2016
Primary completion	1 July 2018
Estimated completion	1 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)

Conditions studied

• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →

Sponsor

Oregon Health and Science University

Who can join

19 and older, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an approach that can assess the total impact of the complex pathophysiologic processes in patients with limb ischemia, particularly in those with diabetes in whom distal arterial disease and abnormal microvascular functional responses are common. This trial is designed to: (a) optimize methods for assessment of limb perfusion at rest and during stress using contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able to provide non-linear signal without destruction at medium acoustic pressures, and (b) to test whether perfusion imaging provides incremental information on the severity of disease in patients with peripheral artery disease.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanoparticles in the clinic: An update.
   Anselmo AC, Mitragotri S. · · 2019 · cited 976× · PMID 31572799 · DOI 10.1002/btm2.10143
2. Nanoparticles in the clinic.
   Anselmo AC, Mitragotri S. · · 2016 · cited 773× · PMID 29313004 · DOI 10.1002/btm2.10003
3. Nanoparticles in the clinic: An update post COVID-19 vaccines.
   Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
4. Targeting of microbubbles: contrast agents for ultrasound molecular imaging.
   Wang S, Hossack JA, Klibanov AL. · · 2018 · cited 71× · PMID 29258335 · DOI 10.1080/1061186x.2017.1419362
5. Contrast Enhanced Ultrasound Perfusion Imaging in Skeletal Muscle.
   Nguyen T, Davidson BP. · · 2019 · cited 17× · PMID 31161755 · DOI 10.4250/jcvi.2019.27.e31
6. Limb Perfusion During Exercise Assessed by Contrast Ultrasound Varies According to Symptom Severity in Patients with Peripheral Artery Disease.
   Davidson BP, Hodovan J, Mason OR, Moccetti F, et al · · 2019 · cited 13× · PMID 31235422 · DOI 10.1016/j.echo.2019.05.001