Computed Tomography, Diagnostic Imaging
Conditions
Keywords
Ultravist 370, CECT, CT Scan
Brief summary
This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician. Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body
Detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
Interventions
DRUGIopromide 370 mg I/mL
Iopromide (Ultravist 370 mg I/mL) administered intravenously
DRUGIopromide 300 mg I/mL
Iopromide (Ultravist 300 mg I/mL) administered intravenously
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.
Exclusion criteria
* Patients that are less than 18 years old and do not have a clinical indication for a contrast-enhanced CT of the head or body.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | post administration assessment of study images | A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | post administration assessment of study images | The number of participants with diagnostic CECTs as assessed by the investigators. |
| The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. | post administration assessment of study images | A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor. |
| The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | post administration assessment of study images | The number of participants with diagnostic CECTs as assessed by the 3 blinded readers. |
Countries
Colombia, India, South Korea, United States
Participant flow
Recruitment details
The recruitment period was 21 Oct 2005 to 11 Apr 2008.
Pre-assignment details
437 subjects were screened; 2 subjects were screen failures because of not meeting inclusion criteria and/or meeting exclusion criteria; 435 subjects were enrolled; 1 enrolled subject withdrew consent before receiving study drug; 434 subjects received study drug and were included in the safety analysis set.
Participants by arm
| Arm | Count |
|---|---|
| Iopromide 370 mg I/mL Iopromide (Ultravist 370 mg I/mL) administered intravenously | 412 |
| Iopromide 300 mg I/mL Iopromide (Ultravist 300 mg I/mL) administered intravenously | 22 |
| Total | 434 |
Baseline characteristics
| Characteristic | Iopromide 370 mg I/mL | Iopromide 300 mg I/mL | Total |
|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 15.15 | 56.5 years STANDARD_DEVIATION 14.54 | 52.1 years STANDARD_DEVIATION 15.13 |
| Sex: Female, Male Female | 191 Participants | 16 Participants | 207 Participants |
| Sex: Female, Male Male | 221 Participants | 6 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 412 | 1 / 22 |
| serious Total, serious adverse events | 2 / 412 | 0 / 22 |
Outcome results
Primary
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.
A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.
Time frame: post administration assessment of study images
Population: The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iopromide 370 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Excellent + Good (blinded reader 1) | 366 Number of participants in QOI grade |
| Iopromide 370 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Poor (blinded reader 1) | 16 Number of participants in QOI grade |
| Iopromide 370 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Excellent + Good (blinded reader 2) | 368 Number of participants in QOI grade |
| Iopromide 370 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Poor (blinded reader 2) | 14 Number of participants in QOI grade |
| Iopromide 370 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Excellent + Good (blinded reader 3) | 376 Number of participants in QOI grade |
| Iopromide 370 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Poor (blinded reader 3) | 6 Number of participants in QOI grade |
| Iopromide 300 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Excellent + Good (blinded reader 3) | 15 Number of participants in QOI grade |
| Iopromide 300 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Excellent + Good (blinded reader 1) | 17 Number of participants in QOI grade |
| Iopromide 300 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Poor (blinded reader 2) | 1 Number of participants in QOI grade |
| Iopromide 300 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Poor (blinded reader 1) | 3 Number of participants in QOI grade |
| Iopromide 300 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Poor (blinded reader 3) | 5 Number of participants in QOI grade |
| Iopromide 300 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | Excellent + Good (blinded reader 2) | 19 Number of participants in QOI grade |
Comparison: Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).95% CI: [93.3, 97.6]
Comparison: Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).95% CI: [93.9, 98]
Comparison: Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).95% CI: [96.6, 99.4]
Secondary
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images
The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.
Time frame: post administration assessment of study images
Population: The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Not applicable (blinded reader 2) | 0 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Yes (blinded reader 1) | 376 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Yes (blinded reader 2) | 382 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | No (blinded reader 3) | 0 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Not applicable (blinded reader 1) | 0 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Not applicable (blinded reader 3) | 1 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | No (blinded reader 2) | 0 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Yes (blinded reader 3) | 381 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | No (blinded reader 1) | 6 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Yes (blinded reader 3) | 20 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | No (blinded reader 1) | 2 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Not applicable (blinded reader 1) | 0 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Yes (blinded reader 1) | 18 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | No (blinded reader 2) | 0 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Not applicable (blinded reader 2) | 0 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | No (blinded reader 3) | 0 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Not applicable (blinded reader 3) | 0 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | Yes (blinded reader 2) | 20 Number of diagnostic CECTs |
Comparison: Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).95% CI: [96.6, 99.4]
Comparison: Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).95% CI: [99, 100]
Comparison: Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).95% CI: [98.6, 100]
Secondary
The Ability of the Investigator to Make a Diagnosis Based on the CECT Images
The number of participants with diagnostic CECTs as assessed by the investigators.
Time frame: post administration assessment of study images
Population: The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iopromide 370 mg I/mL | The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | No | 1 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | Not applicable | 0 Number of diagnostic CECTs |
| Iopromide 370 mg I/mL | The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | Yes | 381 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | No | 0 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | Not applicable | 0 Number of diagnostic CECTs |
| Iopromide 300 mg I/mL | The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | Yes | 20 Number of diagnostic CECTs |
95% CI: [98.6, 100]
Secondary
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.
A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.
Time frame: post administration assessment of study images
Population: The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iopromide 370 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. | Excellent + Good | 380 Number of participants in QOI grade |
| Iopromide 370 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. | Poor | 2 Number of participants in QOI grade |
| Iopromide 300 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. | Excellent + Good | 20 Number of participants in QOI grade |
| Iopromide 300 mg I/mL | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. | Poor | 0 Number of participants in QOI grade |
95% CI: [98.1, 99.9]