Optimization of Contrast Agent Dose in CT With Lean Body Weight (CA_LBW)

Randomized Controlled Trial of Optimization of Contrast Agent Dose in CT With Lean Body Weight

This study evaluates the different enhancement using a contrast agent dose in computed tomography based on total body weight or based on lean body weight. Half of participants will receive contrast agent dose based on their total body weight, while the other half will receive a dose based on their lean body weight. Our hypothesis is that if contrast agent is administered not basing on total body weight but on lean body weight it is possible to obtain equal or better quality of enhanced images, a reduction of the variability of contrast enhancement, and also a dose reduction in some patients (overweight ones).

Study Overview

• Status: Completed
• Conditions: Contrast Agent With Lean Body Weight
• Intervention / Treatment: Drug: Iopamidol

Detailed Description

Patients will undergo a CT scan of abdomen (multi-phasic) with contrast agent and will be measured: total body weight (TBW), height, lean body weight (LBW) and body mass index (BMI) through formulas known in literature and with a balance for bioelectrical impedance analysis. There is no administration of drugs other than those indicated in the request of the treating physician.

Contrast agent dose:

IOPAMIRO® (Iopamidol) is an x-ray contrast medium of the new generation of non-ionic compounds, which are watersoluble because the molecular structure incorporates hydrophilic groups. Recommended dosage (ml) is 0.5-2.0/kg. Single injection volume depends on the vascular area to be examined.

IOMERON® (Iomeprolo) is an x-ray contrast medium of the new generation of non-ionic compounds, which are watersoluble because the molecular structure incorporates hydrophilic groups. Recommended dosage (ml) is 0.5-2.0/kg. Single injection volume depends on the vascular area to be examined.

Patients will be randomly assigned to undergo one of the two contrast agent protocols.

Control group (TBW protocol): patients will receive a contrast agent dose based on their TBW as a standard clinic protocol with a dose of 0.40 gI/kg of TBW. There are no differences compared to clinical practice.

Experimental group (LBW protocol): patients will receive a contrast agent dose based on their calculated LBW to test our hypothesis with a dose of 0.65 gI/kg of LBW, derived from our pilot study (LBW_01 approved 10/11/2016, registration number 160/int/2016).

If radiologists prefer a more enhanced examination, only scanning with contrast agent will be repeated with the standard dose as the standard clinical protocol.

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan
    • San Donato Milanese, Milan, Italy, 20097
      • IRCCS Policlinico San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient ≥ 18 years of age;
• Patients who will perform a contrast-enhanced abdominal CT multi-phasic in our institutions;
• Patients able to give informed consent.

Exclusion Criteria:

• history of chronic underlying liver disease (cirrhosis, fatty infiltration of the liver, or glycogen storage disease);
• history of chronic underlying heart disease (congestive heart failure, prior cardiac valve replacement, restrictive and/or constrictive pericarditis);
• multiple myeloma;
• hypersensitivity to iodine-containing compounds;
• renal insufficiency (serum creatinine level ≤ 1.8 mg/dL [159.12 µmol/L]) or patients with renal failure (eGR <30 ml/min/1.73 m2);
• patients with antecubital vein that, at medical evaluation, cannot sustain the flow rate of CA injection (see below);
• patients carrier of prosthesis or metal bullets, pacemaker or stimulators;
• patients with liver diseases that affect the entire parenchyma;
• fragile patients which, after radiologist evaluation, require lower dose of CA;
• pregnancy;
• general contraindications to CT examination or reasoned decision of the radiologist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: TBW protocol; Patients will receive a contrast agent dose based on their TBW as a standard clinic protocol.	Drug: Iopamidol; Contrast agent will be adrministered intravenously using total body weight or lean body weight, calculated with bioelectrical impedance analysis balance.; Other Names: Iomeprolo
Experimental: LBW protocol; Patients will receive a contrast agent dose based on their calculated LBW.	Drug: Iopamidol; Contrast agent will be adrministered intravenously using total body weight or lean body weight, calculated with bioelectrical impedance analysis balance.; Other Names: Iomeprolo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Enhancement	The liver contrast enhancement (ΔCEL) will be calculated as the difference between the CT value measured in the venous phase and that measured before contrast injection.	1 day

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): February 25, 2019
• Study Completion (Actual): February 25, 2019

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: LBW_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No