Trial · NCT03740997
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
NCT03740997, Phase 4, Completed, GE Healthcare; results first posted 2024-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Determine Safety and Dosage of OPTISON in Pediatric Participants. Trials, record NCT03740997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03740997
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
- NCT number
- NCT03740997
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 39 participants, actual
- Lead sponsor
- GE Healthcare
- Conditions
- Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality
- Interventions
- Optison
- First posted
- 2018-11-14
- Last updated
- 2024-05-17
- Results first posted
- 2024-05-17
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 0- 72 hours | 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. |
| Secondary | Change From Baseline in Systolic and Diastolic Blood Pressure | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | 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). |
| Secondary | Change From Baseline in Heart Rate | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | Before heart rate was measured, participants rested for at least 5 minutes (if possible). |
| Secondary | Change From Baseline in Respiratory Rate | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | Before respiratory rate was measured, participants rested for at least 5 minutes (if possible). |
| Secondary | Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | Oxygen saturation was measured by pulse oximetry. Before oxygen saturation was measured, participants rested for at least 5 minutes (if possible). |
| Secondary | Number of Participants With Clinically Significant Abnormality in Physical Examination Findings | From first dose (Day 1) of study drug to 60 minutes post last dose on Day 1 | 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. |
| Secondary | Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters | Baseline (pre-dose), and at 10 and 30 minutes post last dose on Day 1 | 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. |
| Secondary | Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity | 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 | 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. |
| Secondary | Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling | 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 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 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 | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Each participant underwent an echocardiographic procedure first without contrast administration, then intravenous bolus injection of OPTISON. Here, Number Analyzed signifies participants who were evaluable for specified categories. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 0- 72 hours | The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Systolic and Diastolic Blood Pressure | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study. Here, Number Analyzed signifies participants who were evaluable at specified timepoints. | millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Heart Rate | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study. Here, Number Analyzed signifies participants who were evaluable at specified timepoints. | beats per minute | MEAN |
| SECONDARY | Change From Baseline in Respiratory Rate | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study. Here, Number Analyzed signifies participants who were evaluable at specified timepoints. | breaths per minute | MEAN |
| SECONDARY | Change From Baseline in Oxygen Saturation as Measured by Pulse Oximetry | Baseline (pre-dose), and at 10 and 60 minutes post last dose on Day 1 | The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study. Here, Number Analyzed signifies participants who were evaluable at specified timepoints. | percentage of oxygen saturation | MEAN |
| SECONDARY | Number of Participants With Clinically Significant Abnormality in Physical Examination Findings | From first dose (Day 1) of study drug to 60 minutes post last dose on Day 1 | The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in 12-lead Electrocardiograms (ECGs) Parameters | Baseline (pre-dose), and at 10 and 30 minutes post last dose on Day 1 | The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study. | milliseconds (ms) | MEAN |
| SECONDARY | Number of Participants by Degree of Left Ventricular Opacification (LVO) Assessed by Visual Peak Contrast Intensity | 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 | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Here, Number Analyzed signifies participants who were evaluable for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by Grade of Left Ventricular Opacification (LVO) Assessed by Peak Left Ventricular (LV) Contrast Filling | 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 | PP population consisted of all participants who had available non-contrast harmonic images and OPTISON-enhanced echocardiographic images, irrespective of the quality of CE-echo and who did not have an important protocol deviation impacting study primary endpoint. Here, Number Analyzed signifies participants who were evaluable for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group402
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Body Weight Group <=40 kg: OPTISON | Reader 1: Non-contrast | 15.9 | Standard Deviation 5.73 | score on a scale |
| 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) | Body Weight Group >40 kg: OPTISON | Reader 1: Non-contrast | 10.0 | Standard Deviation 7.02 | score on a scale |
| 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) | Body Weight Group <=40 kg: OPTISON | Reader 1: OPTISON Dose Level 1 | 31.3 | Standard Deviation 6.53 | score on a scale |
| 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) | Body Weight Group >40 kg: OPTISON | Reader 1: OPTISON Dose Level 1 | 26.6 | Standard Deviation 12.50 | score on a scale |
| 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) | Body Weight Group <=40 kg: OPTISON | Reader 1: OPTISON Dose Level 2 | 35.1 | Standard Deviation 2.27 | score on a scale |
| 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) | Body Weight Group >40 kg: OPTISON | Reader 1: OPTISON Dose Level 2 | 28.6 | Standard Deviation 10.36 | score on a scale |
| 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) | Body Weight Group <=40 kg: OPTISON | Reader 2: Non-contrast | 13.4 | Standard Deviation 2.57 | score on a scale |
| 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) | Body Weight Group >40 kg: OPTISON | Reader 2: Non-contrast | 8.5 | Standard Deviation 6.49 | score on a scale |
| 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) | Body Weight Group <=40 kg: OPTISON | Reader 2: OPTISON Dose Level 1 | 32.8 | Standard Deviation 1.47 | score on a scale |
| 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) | Body Weight Group >40 kg: OPTISON | Reader 2: OPTISON Dose Level 1 | 28.1 | Standard Deviation 10.34 | score on a scale |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Body Weight Group >40 kg: OPTISON | 31 | |
| Overall Study | STARTED | Body Weight Group <=40 kg: OPTISON | 8 | |
| Overall Study | Safety Population (Treated) | Body Weight Group >40 kg: OPTISON | 29 | |
| Overall Study | Safety Population (Treated) | Body Weight Group <=40 kg: OPTISON | 8 | |
| Overall Study | Per-protocol (PP) Population | Body Weight Group >40 kg: OPTISON | 23 | |
| Overall Study | Per-protocol (PP) Population | Body Weight Group <=40 kg: OPTISON | 7 | |
| Overall Study | COMPLETED | Body Weight Group >40 kg: OPTISON | 29 | |
| Overall Study | COMPLETED | Body Weight Group <=40 kg: OPTISON | 8 | |
| Overall Study | NOT COMPLETED | Body Weight Group >40 kg: OPTISON | 2 | |
| Overall Study | NOT COMPLETED | Body Weight Group <=40 kg: OPTISON | 0 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Supraventricular extrasystoles | Cardiac disorders | Body Weight Group <=40 kg: OPTISON | 0 | 8 | |
| other | Supraventricular extrasystoles | Cardiac disorders | Body Weight Group >40 kg: OPTISON | 1 | 29 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Body Weight Group <=40 kg: OPTISON | 0 | 8 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Body Weight Group >40 kg: OPTISON | 1 | 29 | |
| other | Abdominal pain | Gastrointestinal disorders | Body Weight Group <=40 kg: OPTISON | 1 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Body Weight Group >40 kg: OPTISON | 2 | 29 | |
| other | Diarrhoea | Gastrointestinal disorders | Body Weight Group <=40 kg: OPTISON | 0 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | Body Weight Group >40 kg: OPTISON | 2 | 29 | |
| other | Nausea | Gastrointestinal disorders | Body Weight Group <=40 kg: OPTISON | 1 | 8 | |
| other | Nausea | Gastrointestinal disorders | Body Weight Group >40 kg: OPTISON | 2 | 29 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Body Weight Group <=40 kg: OPTISON | 0 | 8 |
| Total, all-cause mortality | Body Weight Group >40 kg: OPTISON | 0 | 29 |
| Total, other adverse events | Body Weight Group <=40 kg: OPTISON | 4 | 8 |
| Total, other adverse events | Body Weight Group >40 kg: OPTISON | 9 | 29 |
| Total, serious adverse events | Body Weight Group <=40 kg: OPTISON | 0 | 8 |
| Total, serious adverse events | Body Weight Group >40 kg: OPTISON | 0 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Body Weight Group <=40 kg: OPTISON vs Body Weight Group >40 kg: OPTISON: deaths from any cause | Trial comparisons |
| Body Weight Group <=40 kg: OPTISON vs Body Weight Group >40 kg: OPTISON: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Body Weight Group <=40 kg: OPTISON vs Body Weight Group >40 kg: OPTISON: Number of Participants With Clinically Significant Abnormality in Physical Examination Findings | Trial comparisons |
| Body Weight Group <=40 kg: OPTISON vs Body Weight Group >40 kg: OPTISON: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03740997
GET https://conductscience.org/api/trials/v1/NCT03740997/results?page=2