Trial Outcomes & Findings for Customized Contrast Media Dose Clinical Trial (NCT NCT02433665)
NCT ID: NCT02433665
Last Updated: 2020-06-16
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
166 participants
Primary outcome timeframe
During CT scan, approximately 5 minutes
Results posted on
2020-06-16
Participant Flow
A total of 10 enrolled subjects either screen failed or were withdrawn by the PI prior to randomization. Four subjects screen failed due to changes in their clinical orders prior to imaging. Six subjects were withdrawn by the PI due to patient scheduling conflicts.
Participant milestones
| Measure |
Fixed Dose
100 of the first 200 subjects will be randomized to a fixed dose of contrast material.
Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
|
Customized Dose
100 of the first 200 subjects will be randomized to a customized dose of contrast material based on the experimental algorithm. The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm.
Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
Mydose: 400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters.
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|---|---|---|
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Overall Study
STARTED
|
77
|
79
|
|
Overall Study
COMPLETED
|
77
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Customized Contrast Media Dose Clinical Trial
Baseline characteristics by cohort
| Measure |
Fixed Dose
n=77 Participants
100 of the first 200 subjects will be randomized to a fixed dose of contrast material.
Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
|
Customized Dose
n=79 Participants
100 of the first 200 subjects will be randomized to a customized dose of contrast material based on the experimental algorithm. The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm.
Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
Mydose: 400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
63.2 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 12 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During CT scan, approximately 5 minutesOutcome measures
| Measure |
Fixed Dose
n=77 Participants
100 of the first 200 subjects will be randomized to a fixed dose of contrast material.
Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
|
Customized Dose
n=79 Participants
100 of the first 200 subjects will be randomized to a customized dose of contrast material based on the experimental algorithm. The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm.
Iopamidol: Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
Mydose: 400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters.
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|---|---|---|
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Variability in Enhancement Data, Measured in Hounsfield Units (HU)
|
199 Hounsfield Units (HU)
Standard Deviation 45
|
205 Hounsfield Units (HU)
Standard Deviation 50
|
Adverse Events
Fixed Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Customized Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place