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Study to Determine Dosage of OPTISON in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03740997
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
Study to determine the safety and appropriate dosage of OPTISON in pediatric patients since OPTISON has been tested in adult patients only during the clinical development

Condition or disease Intervention/treatment Phase
Study to Determine Dosage of OPTISON in Children Between ≥9 and <18 Years of Age Weighing ≥20 kg Drug: Optison Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 4, Open-Label, Non-randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of OPTISON™ for Contrast- Enhanced Echocardiography in Pediatric Patients
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: Patients with body weight ≥20 to ≤28 kg
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.
Drug: Optison
Optison is administered intravenously
Other Name: Perflutren Microspheres Injectable Suspension, USP

Experimental: Patients with body weight >28 to ≤40 kg
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.
Drug: Optison
Optison is administered intravenously
Other Name: Perflutren Microspheres Injectable Suspension, USP

Experimental: Patients with body weight >40 kg
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.
Drug: Optison
Optison is administered intravenously
Other Name: Perflutren Microspheres Injectable Suspension, USP




Primary Outcome Measures :
  1. 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. [ Time Frame: 72 hours ]

    A qualitative score will be assigned to each left ventricle (LV) segment:

    0 = no visualization of the LV endocardial border

    1. = poor visualization
    2. = fair visualization
    3. = good/optimal visualization


Secondary Outcome Measures :
  1. Overall safety profile in terms of occurrence of adverse events (AEs) following administration of OPTISON. [ Time Frame: 72 hours ]
  2. Overall safety profile in terms of changes in measurements of systolic and diastolic blood pressure following administration of OPTISON. [ Time Frame: 72 hours ]
  3. Overall safety profile in terms of changes in heart rate following administration of OPTISON. [ Time Frame: 72 hours ]
  4. Overall safety profile in terms of changes in respiratory rate following administration of OPTISON. [ Time Frame: 72 hours ]
  5. Overall safety profile in terms of changes in pulse oximetry following administration of OPTISON. [ Time Frame: 72 hours ]
  6. Overall safety profile in terms of arterial oxygen saturation (SaO2) following administration of OPTISON. [ Time Frame: 72 hours ]
  7. Overall safety profile in terms of physical examinations following administration of OPTISON. [ Time Frame: 72 hours ]
  8. Overall safety profile in terms of 12-lead electrocardiograms (ECGs) following administration of OPTISON. [ Time Frame: 72 hours ]
    Descriptive statistics will be used to describe the observed values and change from baseline for ECG intervals (heart rate, PR, RR, QRS, QT, QTcB [Bazett], QTcF [Fridericia]).

  9. Left ventricular opacification (LVO) assessed by visual peak contrast intensity following intravenous administration of OPTISON at various doses. [ Time Frame: 72 hours ]
  10. Left ventricular opacification (LVO) assessed by peak LV contrast filling following intravenous administration of OPTISON at various doses. [ Time Frame: 72 hours ]
  11. Duration of contrast enhancement following intravenous administration of OPTISON at various doses. [ Time Frame: 72 hours ]

Other Outcome Measures:
  1. Comparison of diagnostic confidence of LV EBD and wall motion between non-contrast and OPTISON-enhanced echocardiography at various doses. [ Time Frame: 72 hours ]
  2. Comparison of diagnostic confidence in the evaluation of LVEF between non-contrast and OPTISON-enhanced echocardiography. [ Time Frame: 72 hours ]


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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is between ≥9 and <18 years of age and weighs ≥20 kg.
  • The subject is clinically indicated to undergo a transthoracic echocardiogram.
  • The subject has a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized.
  • The subject is able to comply with study procedures.
  • A parent or legal guardian of the subject has signed and dated an informed consent form.

Exclusion Criteria:

  • The subject was previously enrolled in this study.
  • The subject has received an investigational medicinal product within 30 days before or is scheduled to receive one from time of entry into this study until completion of the follow-up period proposed for this study.
  • The subject has a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin.
  • The subject has pulmonary hypertension or unstable cardiopulmonary conditions.
  • The subject has severe liver disease based on medical history.
  • The subject had a recent (<6 months) neurological event.
  • The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740997


Contacts
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Contact: Michelle Straszacker +44 (0) 1491 44 3173 Michelle.Straszacker@ge.com
Contact: Alletah Schmidt (774) 249-6290 Alletah.Schmidt@ge.com

Sponsors and Collaborators
GE Healthcare
Covance
Investigators
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Study Director: Francois Tranquart, M.D., Ph.D. GE Healthcare

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03740997     History of Changes
Other Study ID Numbers: GE-191-008
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GE Healthcare:
Contrast-enhanced echocardiography (CE-ECHO)
Transthoracic echocardiogram
Child
Left ventricular opacification (LVO)
Left ventricular ejection fraction (LVEF)
Left ventricular endocardial border delineation (LV EBD)