Transthoracic EchocardiographyPhase 4NCT03740997
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
A Phase 4 study testing Optison in people with Transthoracic Echocardiography and Suspected or Known Structural or Functional Cardiac Abnormality, run by GE Healthcare at 8 sites in United States.
Trial summary
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality
- What is being tested?
- Optison
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Dec 2020to 30 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participant was between ≥9 and <18 years of age and weighs ≥20 kg.
- The participant was clinically indicated to undergo a transthoracic echocardiogram.
- The participant had a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized.
- The participant was able to comply with study procedures.
- A parent or legal guardian of the participant had signed and dated an informed consent form.
- Post-menarchal female participants must have had a negative urine pregnancy test at screening and at pre-dose on the day of OPTISON administration.
- Post-menarchal female participants must have been practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study
Who cannot join
- The participant was previously enrolled in this study.
- The participant 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 participant had a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin.
- The participant had pulmonary hypertension or unstable cardiopulmonary conditions.
- The participant had severe liver disease based on medical history.
- The participant had a recent (<6 months) neurological event.
- The participant presented 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 participant or other reason that in the judgment of the investigator makes the participant unsuitable for participation in the study.
- The participant was a pregnant or lactating female, or was a female of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test was also required).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
MCG Health, Inc.
Augusta, Georgia, 30912
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
Cohen Children's Medical Center of New York
Lake Success, New York, 11042
Children's Hospital Los Angeles
Los Angeles, California, 90027
Phoenix Children's Hospital
Phoenix, Arizona, 85016
About this study
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
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development
- Conditions
- Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality
- Being tested
- Optison
- Keywords
- Contrast-enhanced echocardiography (CE-ECHO), Transthoracic echocardiogram, Child, Left ventricular opacification (LVO), Left ventricular ejection fraction (LVEF), Left ventricular endocardial border delineation (LV EBD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptisonDrug
Also called Perflutren Microspheres Injectable Suspension, USP
Optison is administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Body Weight Group <=40 kg: OPTISON | Experimental | Participants with body weight greater than or equal to (>=) 20 to less than or equal to (<=) 28 kilograms (kg) received OPTISON 0.1 milliliter (mL; dose level 1) or 0.2 mL (dose level 2); and participants with body weight greater than (>) 28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) intravenous (IV) injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively.
The treated subjects received both dose levels. Per protocol, up to 3 injections per dose level were allowed for acquiring different imaging views. A maximum of 2 injections was recorded in the treated population. Receives: Drug: Optison |
| Body Weight Group >40 kg: OPTISON | Experimental | Participants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level.
The treated subjects received both dose levels. Per protocol, up to 3 injections per dose level were allowed for acquiring different imaging views. A maximum of 2 injections was recorded in the treated population. Receives: Drug: Optison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Visualization Score of Qualitative Endocardial Border Delineation (EBD) of the 12 Segments of the Left Ventricle (LV) Wall in Standard Apical 4-chamber (A4C) and Apical 2-chamber (A2C)
Visualization of each of the 12 segments of the LV wall in standard A4C and A2C views were measured by the qualitative EBD visualization scale: score 0 =no visualization of the LV endocardial border; 1 =poor visualization; 2 =fair visualization; 3 =good/optimal visualization. The total LV EBD score was calculated as the sum of the individual scores assigned to each of the 12 LV wall segment and the total score ranged from 0 (no visualization of the LV endocardial border) to 36 (good/optimal visualization). A higher score indicated better visualization. The total score of qualitative EBD visualization scale were reported by reader (independent blinded), non-contrast and dose levels.
Measured: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Secondary outcomes (12)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that starts or worsens at or after the time of first dosing of OPTISON.
Measured: 0- 72 hours
Change From Baseline in Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure were measured from the arm contra-lateral to the site of OPTISON administration whenever possible and before measurement, participants rested for at least 5 minutes (if possible).
Measured: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1
Change From Baseline in Heart Rate
Before heart rate was measured, participants rested for at least 5 minutes (if possible).
Measured: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1
Change From Baseline in Respiratory Rate
Before respiratory rate was measured, participants rested for at least 5 minutes (if possible).
Measured: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1
Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry
Oxygen saturation was measured by pulse oximetry. Before oxygen saturation was measured, participants rested for at least 5 minutes (if possible).
Measured: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1
Number of Participants With Clinically Significant Abnormality in Physical Examination Findings
Participants underwent assessments including general appearance, respiratory, cardiovascular and neurological (motor function, level of consciousness, sensory function) examination. Any abnormal clinically significant physical examination findings were based on investigator decision.
Measured: From first dose (Day 1) of study drug to 60 minutes post last dose on Day 1
Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters
Change from baseline in PR, QRS, QT, Bazett's formula corrected QT (QTcB), Fridericia's formula corrected QT (QTcF) and RR intervals expressed in millisecond (ms) were reported.
Measured: Baseline (pre-dose), and at 10 and 30 minutes post last dose on Day 1
Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity
LVO peak contrast intensity was determined by readers (independent blinded) using a categorical scale as None, Low, Medium, High or Blooming, where, None = Absence of contrast signal; Low = Limited capacity to make a diagnostic assessment; Presence of contrast signal does not improve diagnostic interpretability to a great degree; Medium = Good capacity to make a diagnostic assessment; Contrast signal facilitates diagnostic interpretability to a good degree; High = Optimal capacity to make a diagnostic assessment; Contrast signal facilitates diagnostic interpretability to a high degree; Blooming = Oversaturation of the signal disrupts diagnostic interpretability. Tissue boundaries become challenging to delineate. There may be excessive acoustic shadowing in the far-field of the image. Number of participants by degree of LVO assessed by visual peak contrast intensity was presented by readers and dose levels.
Measured: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling
Peak LV contrast filling for LVO was categorized as: 0 = none (0 percent [%] filling); 1 = faint (around 33% filling); 2 = intermediate (around 67% filling); 3 = full (100% filling) and data were presented by readers (independent blinded) and dose levels.
Measured: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber
Contrast enhancement duration was determined from the time the contrast appeared in the LV to the time the contrast almost dissipated from the left chamber. 3 independent blinded reader performed evaluation.
Measured: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images
Diagnostic confidence for the assessment of LV EBD and wall motion was scored for non-contrast and OPTISON-enhanced echocardiographic acquisitions separately using a 4-point scale which ranged from ranged 0 to 4, where 0 = no confidence, 1 = low confidence, 2 = moderate confidence, 3 = high confidence. A higher score indicates better confidence level. Data were presented by reader (independent blinded), non-contrast and dose levels.
Measured: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography
Diagnostic confidence for the evaluation of LVEF was calculated using the formula: (end diastole volume - end systole volume)/(end diastole volume) was scored for non-contrast and OPTISON-enhanced echocardiographic acquisitions separately using a 4-point scale which ranged from 0 to 3, where 0 = no confidence, 1 = low confidence, 2 = moderate confidence, 3 = high confidence. A higher score indicates better confidence level. Data were presented by reader (independent blinded), non-contrast and dose levels.
Measured: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Dec 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transthoracic EchocardiographyStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- David Thompson, MD, PhD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740997
- Sponsor's protocol ID
- GE-191-008
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2018
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03740997
- Acronym / sponsor ID
- GE-191-008
- Conditions
- Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality
- Keywords
- Contrast-enhanced echocardiography (CE-ECHO), Transthoracic echocardiogram, Child, Left ventricular opacification (LVO), Left ventricular ejection fraction (LVEF), Left ventricular endocardial border delineation (LV EBD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Weight Group <=40 kg: OPTISON | Experimental | Drug: OptisonParticipants with body weight greater than or equal to (>=) 20 to less than or equal to (<=) 28 kilograms (kg) received OPTISON 0.1 milliliter (mL; dose level 1) or 0.2 mL (dose level 2); and participants with body weight greater than (>) 28 to <=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) intravenous (IV) injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight >=20 to <=28 kg and >28 to <=40 kg was 1.0 mL and 1.5 mL per dose level, respectively. The treated subjects received both dose levels. Per protocol, up to 3 injections per dose level were allowed for acquiring different imaging views. A maximum of 2 injections was recorded in the treated population. |
| Body Weight Group >40 kg: OPTISON | Experimental | Drug: OptisonParticipants with body weight >40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level. The treated subjects received both dose levels. Per protocol, up to 3 injections per dose level were allowed for acquiring different imaging views. A maximum of 2 injections was recorded in the treated population. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The participant was between ≥9 and <18 years of age and weighs ≥20 kg.
- The participant was clinically indicated to undergo a transthoracic echocardiogram.
- The participant had a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized.
- The participant was able to comply with study procedures.
- A parent or legal guardian of the participant had signed and dated an informed consent form.
Key exclusion criteria (8 listed)
- The participant was previously enrolled in this study.
- The participant 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 participant had a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin.
- The participant had pulmonary hypertension or unstable cardiopulmonary conditions.
- The participant had severe liver disease based on medical history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptisonAlso: Perflutren Microspheres Injectable Suspension, USPOptison is administered intravenously | Drug | Body Weight Group <=40 kg: OPTISON, Body Weight Group >40 kg: OPTISON |
Primary outcome
Mean Total Visualization Score of Qualitative Endocardial Border Delineation (EBD) of the 12 Segments of the Left Ventricle (LV) Wall in Standard Apical 4-chamber (A4C) and Apical 2-chamber (A2C)
Time frame: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Visualization of each of the 12 segments of the LV wall in standard A4C and A2C views were measured by the qualitative EBD visualization scale: score 0 =no visualization of the LV endocardial border; 1 =poor visualization; 2 =fair visualization; 3 =good/optimal visualization. The total LV EBD score was calculated as the sum of the individual scores assigned to each of the 12 LV wall segment and the total score ranged from 0 (no visualization of the LV endocardial border) to 36 (good/optimal visualization). A higher score indicated better visualization. The total score of qualitative EBD visualization scale were reported by reader (independent blinded), non-contrast and dose levels.
12 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 0- 72 hours
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1
Change From Baseline in Heart Rate
Time frame: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1
Change From Baseline in Respiratory Rate
Time frame: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1
Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry
Time frame: Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1
Number of Participants With Clinically Significant Abnormality in Physical Examination Findings
Time frame: From first dose (Day 1) of study drug to 60 minutes post last dose on Day 1
Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters
Time frame: Baseline (pre-dose), and at 10 and 30 minutes post last dose on Day 1
Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity
Time frame: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling
Time frame: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Number of Participants by Contrast Enhancement Duration in the Left Ventricular (LV) Chamber
Time frame: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Number of Participants by Diagnostic Confidence of Left Ventricular Endocardial Border Delineation (LV EBD) and Wall Motion for Contrast and Non-Contrast Enhanced Images
Time frame: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Number of Participants by Diagnostic Confidence of Left Ventricular Ejection Fraction (LVEF) for Non-contrast and OPTISON Enhanced Echocardiography
Time frame: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Thompson, MD, PhD study director
GE Healthcare
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Optison in people with Transthoracic Echocardiography and Suspected or Known Structural or Functional Cardiac Abnormality, run by GE Healthcare at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Total Visualization Score of Qualitative Endocardial Border Delineation (EBD) of the 12 Segments of the Left Ventricle (LV) Wall in Standard Apical 4-chamber (A4C) and Apical 2-chamber (A2C) (time frame: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.