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Ultrasound Contrast Agent

Optison for OPTISON Dosage Study in Children

Phase 4
Waitlist Available
Research Sponsored by GE Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial will help researchers understand how safe and effective OPTISON is for kids.

Eligible Conditions
  • OPTISON Dosage Study in Children

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visualization of the 12 segments of the left ventricle wall in standard apical 4-chamber and 2-chamber views measured by the qualitative endocardial border delineation (EBD) visualization scale.
Secondary outcome measures
Duration of contrast enhancement following intravenous administration of OPTISON at various doses.
Left ventricular opacification (LVO) assessed by peak LV contrast filling following intravenous administration of OPTISON at various doses.
Left ventricular opacification (LVO) assessed by visual peak contrast intensity following intravenous administration of OPTISON at various doses.
+8 more
Other outcome measures
Comparison of diagnostic confidence in the evaluation of LVEF between non-contrast and OPTISON-enhanced echocardiography.
Comparison of diagnostic confidence of LV EBD and wall motion between non-contrast and OPTISON-enhanced echocardiography at various doses.

Side effects data

From 2019 Phase 4 trial • 40 Patients • NCT02625428
10%
Major Bleeding Complications
100%
80%
60%
40%
20%
0%
Study treatment Arm
For Cause
Surveillance

Trial Design

3Treatment groups
Experimental Treatment
Group I: Patients with body weight ≥20 to ≤28 kgExperimental Treatment1 Intervention
In children weighing ≥20 to ≤28 kg, 0.1 or 0.2 mL of OPTISON per injection will be given in ascending order. The cumulative dose will not exceed 1.0 mL.
Group II: Patients with body weight >40 kgExperimental Treatment1 Intervention
For children whose weight is >40 kg, 0.2 or 0.4 mL of OPTISON per injection will be administered in ascending order with total dose not to exceed 1.8 mL.
Group III: Patients with body weight >28 to ≤40 kgExperimental Treatment1 Intervention
If children weigh >28-≤40 kg, 0.2 or 0.3 mL of OPTISON per injection will be administered in ascending order with total dose not to exceed 1.5 mL.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Optison
2002
Completed Phase 4
~150

Find a Location

Who is running the clinical trial?

Laboratory Corporation of AmericaIndustry Sponsor
27 Previous Clinical Trials
9,848 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,779 Total Patients Enrolled
GE HealthcareLead Sponsor
289 Previous Clinical Trials
631,019 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to register as a participant in this research study?

"The trial is seeking 50 minors aged between 9 and 17 who meet the following criteria: clinically indicated for a transthoracic echocardiogram, weighing 20kg or more, having suboptimal non-contrast echocardiograms in at least 2 images, able to comply with study procedures, and have parental/legal guardian consent."

Answered by AI

Does the eligibility criteria for this research study permit individuals over 20 years of age to participate?

"This clinical trial demands that applicants are aged between 9 and 17 years old. 37 studies have been conducted to recruit minors, whereas 92 trials are open to geriatric individuals."

Answered by AI

What adverse effects might patients encounter when using Optison?

"Optison has been approved for use, and therefore our team at Power deemed it worthy of a 3 on the safety scale."

Answered by AI

How many individuals have enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov affirms that this clinical trial, initially posted on December 1st 2020, is still actively recruiting participants. 50 individuals need to be recruited from 7 distinct medical locations."

Answered by AI

Are there multiple facilities participating in this exploration within the state?

"This study has recruited participants from many sites, including Children's Hospital Los Angeles in California, Cleveland Clinic Foundation in Ohio, and Ann & Robert H. Lurie Children's Hospital of Chicago in Illinois."

Answered by AI

What prior research has been conducted related to Optison?

"Presently, 19 Optison trials are underway with 1 in Phase 3. Philadelphia, Pennsylvania is the primary site of these tests; however, studies for this drug can be found at 26 distinct locations."

Answered by AI

For what conditions is Optison typically recommended?

"Optison is a therapeutic agent employed in echocardiography, as well as for the diagnosis and management of cardiovascular diseases and left ventricular imaging."

Answered by AI

Are there still participation opportunities available in this research trial?

"Affirmative. Evidently, recruitment for this experiment commenced on the first of December 2020, with a more recent update occurring on July 15th 2022. This clinical trial is looking to recruit 50 individuals from across 7 different centers."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Cohen Children's Medical Center of New York
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Determine Dosage of OPTISON in Pediatric Patients
2020. "Study to Determine Dosage of OPTISON in Pediatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03740997.
~9 spots leftby Apr 2025
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