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A Comparison of the Efficacy & Safety

of Iopamidol-370 and Iodixanol-320 in
Patients Undergoing Multidetector-row
Computed Tomography

Additional findings from the IMPACT Study

Dushyant V. Sahani, Gilles Sowlez, MD, Ke-Min Chen, MD, Luigi Lepanto, MD, Jian-
Rong Xu, MD, Rendon C. Nelson, MD, Luigi Grazioli, MD, Angelo Vanzulli, MD, Jay
P. Heiken, MD, and the Investigators of the IMPACT Study

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Reminder

• Data from the IMPACT Study on the comparison

of the renal tolerability assessment were
published in Investigative Radiology last year

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Additional investigation objectives of the
IMPACT Study

• To prospectively compare the effects of

iopamidol-370 and iodixanol-320 on:
– heart rate (HR) and
– contrast enhancement efficacy
in renally-impaired patients undergoing contrast-
enhanced, multidetector-row computed
tomography (CE-MDCT).

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Study Design
• Multicenter (15 centers), double-blind, parallel
group comparison

• Patients were assigned randomly to receive

the intravenous (I.V.) injection of Iopamidol-
370 or VisipaqueTM 320 (iodixanol injection)

• All groups and individuals associated with the

study remained blinded until the database was
locked and the data analyzed

Visipaque™ (iodixanol injection) is a trademark of GE Healthcare.

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Study Patients

• A total of 166 patients,

–18 years of age or older
–with stable, pre-existing moderate-
to-severe kidney disease
–referred for CE-MDCT examination
of the liver or peripheral vasculature

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Contrast Injection Protocol

• The total iodine dose was set at 40 gI for all

patients (equating to 108 mL of Iopamidol-370
or 125 mL of Iodixanol-320)
• Both contrast agents were injected via an 18-
20-gauge IV angiocatheter at 4 mL/s
• The injection of the contrast agents was
followed by a 20 mL saline flush at 4 mL/s

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Imaging Protocol
• CT images were acquired with 16 slice MDCT scanners using
– kVp of 140
– mAs of 250-380
– 0.5 s rotation time
– Pitch of 1.75
– Table speed of 17.5 mm/rotation
• Scan delay during the arterial phase was determined individually
by means of semiautomatic bolus tracking devices (varied by
center)
• Image acquisition during the portal venous phase was initiated
20 s after the start of arterial phase imaging
• CT images were reconstructed at 2.5 mm section thickness and
5 mm intervals

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Monitoring Heart Rate

• Heart rate (HR) measured with patients in

supine position (on CT table)
• Baseline HR (bpm) was obtained within 5
min before CM injection
• HR was monitored continuously from start
of CM injection for 5 min
• Peak post-dose HR was recorded

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Measurement of Contrast Enhancement

• Images from liver MDCT exams were independently

evaluated by 2 expert radiologists:
– with >15 years abdominal imaging experience,
– unaffiliated with study centers,
– and fully blinded to the CM used

• The blinded readers performed quantitative Hounsfield

Unit (HU) measurements at 4 predefined regions of
interest (ROIs):
– Arterial phase: proximal abdominal aorta
– Portal venous phase: main portal vein, inferior vena
cava, and normal liver parenchyma

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Comparability of Study Groups

* Isovue is the Bracco trade name of Iopamidol in U.S.

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 Contrast Media
Heart Rate Effects

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Effects on Heart Rate

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Effects on Heart Rate

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Contrast Enhancement

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 Arterial Phase

ROI Reader Parameter Iopamidol Iodixanol Difference 95% CI p-

370 320 (Iopamidol value
Iodixanol)
Reader N 56 59
1
Mean 301.3 273.6
Proximal Lsmean 303.2 271.8 31.4 (6.1, 0.02
Abdominal 56.8)
Aorta SE 9.2 8.9
Reader N 55 59
2
Mean 300.1 276.0
Lsmean 301.9 275.1 26.8 (2.3, 0.03
51.3)
SE 8.9 8.6

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 Portal Phase

ROI Reader Parameter Iopamidol Iodixanol Difference 95% CI p-

370 320 (Iopamidol value
Iodixanol)

Liver Reader N 55 60
Parenchyma 1
Mean 113.4 112.0

Lsmean 113.4 111.9 1.4 (-5.5, 0.7

8.4)

SE 2.5 2.4

Reader N 56 61
2
Mean 111.9 108.5
Lsmean 112.1 108.3 3.8 (-3.2, 0.3
10.7)

SE 2.5 2.4

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Conclusions of this study

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