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

Primary Purpose

Contrast Agent With Lean Body Weight

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Iopamidol
Sponsored by
IRCCS Policlinico S. Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Contrast Agent With Lean Body Weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Policlinico San Donato

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

TBW protocol

LBW protocol

Arm Description

Patients will receive a contrast agent dose based on their TBW as a standard clinic protocol.

Patients will receive a contrast agent dose based on their calculated LBW.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2017
Last Updated
May 2, 2019
Sponsor
IRCCS Policlinico S. Donato
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1. Study Identification

Unique Protocol Identification Number
NCT03384979
Brief Title
Optimization of Contrast Agent Dose in CT With Lean Body Weight
Acronym
CA_LBW
Official Title
Randomized Controlled Trial of Optimization of Contrast Agent Dose in CT With Lean Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Agent With Lean Body Weight

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The study design is monocentric, comparative, randomized, double blinded. Patients will undergo a CT scan of abdomen (multi-phasic) with contrast agent and will be measured: TBW, height, 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 indicated in the request of the treating physician.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Patients will be assigned to the TBW or LBW group based on a randomization generated by a computer, the progressive sequences containing the randomization code will be perform by an outside operator to the experiment group. Only CT technician and nurse that will record patient's data and results from scale analysis will know and will register in which group the patients will be assigned.
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TBW protocol
Arm Type
Placebo Comparator
Arm Description
Patients will receive a contrast agent dose based on their TBW as a standard clinic protocol.
Arm Title
LBW protocol
Arm Type
Experimental
Arm Description
Patients will receive a contrast agent dose based on their calculated LBW.
Intervention Type
Drug
Intervention Name(s)
Iopamidol
Other Intervention Name(s)
Iomeprolo
Intervention Description
Contrast agent will be adrministered intravenously using total body weight or lean body weight, calculated with bioelectrical impedance analysis balance.
Primary Outcome Measure Information:
Title
Contrast Enhancement
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
Milan
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimization of Contrast Agent Dose in CT With Lean Body Weight

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