Trial Outcomes & Findings for Use of Electrical Impedence to Measure Lean Body Weight as a Determinant of the Dose of Contrast Media for Abdominal CT (NCT NCT02170688)

Results Overview

Operator-defined regions-of-interest (ROI) will be obtained from liver parenchyma, the portal vein and the abdominal aorta prior to contrast administration and on each slice through the liver post-contrast. Sum of all three areas reported as Summed measurement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

139 participants

Primary outcome timeframe

baseline, post-dose imaging (approximately 1hr)

Results posted on

2015-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Fixed Dose 50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.	Total Body Weight 25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Calculated Lean Body Weight 25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated. Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Measured Lean Body Weight 50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated. Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Estimated Lean Body (eLBW) Weight 25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation
Overall Study STARTED	29	29	29	27	25
Overall Study COMPLETED	25	26	25	25	25
Overall Study NOT COMPLETED	4	3	4	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Fixed Dose 50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.	Total Body Weight 25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Calculated Lean Body Weight 25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated. Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Measured Lean Body Weight 50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated. Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation
Overall Study Exclusion Criteria: Fatty Liver	4	2	3	2
Overall Study Full dose not received	0	1	0	0
Overall Study Physician Decision	0	0	1	0

Baseline Characteristics

Use of Electrical Impedence to Measure Lean Body Weight as a Determinant of the Dose of Contrast Media for Abdominal CT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fixed Dose n=29 Participants 50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.	Total Body Weight n=29 Participants 25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Calculated Lean Body Weight n=29 Participants 25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated. Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Measured Lean Body Weight n=27 Participants 50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated. Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Estimated Lean Body (eLBW) Weight n=25 Participants 25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Total n=139 Participants Total of all reporting groups
Age, Customized ≥18 years	29 participants n=5 Participants	29 participants n=7 Participants	29 participants n=5 Participants	27 participants n=4 Participants	25 participants n=21 Participants	139 participants n=10 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	12 Participants n=21 Participants	61 Participants n=10 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants	14 Participants n=4 Participants	13 Participants n=21 Participants	78 Participants n=10 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	29 participants n=5 Participants	27 participants n=4 Participants	25 participants n=21 Participants	139 participants n=10 Participants

PRIMARY outcome

Timeframe: baseline, post-dose imaging (approximately 1hr)

Operator-defined regions-of-interest (ROI) will be obtained from liver parenchyma, the portal vein and the abdominal aorta prior to contrast administration and on each slice through the liver post-contrast. Sum of all three areas reported as Summed measurement.

Outcome measures

Outcome measures
Measure	Fixed Dose n=25 Participants 50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.	Total Body Weight n=26 Participants 25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Calculated Lean Body Weight n=25 Participants 25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated. Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Measured Lean Body Weight n=25 Participants 50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated. Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation	Estimated Lean Body (eLBW) Weight n=25 Participants 25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg). Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert. Weight calculation
Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) Summed Measurement	419 Hounsfield units (HU) Standard Deviation 50	443 Hounsfield units (HU) Standard Deviation 51	433 Hounsfield units (HU) Standard Deviation 50	426 Hounsfield units (HU) Standard Deviation 33	461 Hounsfield units (HU) Standard Deviation 56
Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) Liver	116 Hounsfield units (HU) Standard Deviation 15	124 Hounsfield units (HU) Standard Deviation 13	121 Hounsfield units (HU) Standard Deviation 14	120 Hounsfield units (HU) Standard Deviation 11	124 Hounsfield units (HU) Standard Deviation 12.6
Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) Portal Vein	158 Hounsfield units (HU) Standard Deviation 21	167 Hounsfield units (HU) Standard Deviation 24	164 Hounsfield units (HU) Standard Deviation 24	161 Hounsfield units (HU) Standard Deviation 17	183 Hounsfield units (HU) Standard Deviation 30.9
Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU) Aorta	145 Hounsfield units (HU) Standard Deviation 18	152 Hounsfield units (HU) Standard Deviation 17	148 Hounsfield units (HU) Standard Deviation 18	145 Hounsfield units (HU) Standard Deviation 13	153 Hounsfield units (HU) Standard Deviation 20

SECONDARY outcome

Timeframe: baseline, post-dose imaging (approximately 1hr)