Optimization of Contrast Agent Dose in CT With Lean Body Weight

NCT03384979 | Completed Phase 4 DMC

• 1 other identifier: LBW_02
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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).

Conditions

Contrast Agent With Lean Body Weight

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TBW protocol

PLACEBO COMPARATOR

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

Drug: Iopamidol

LBW protocol

EXPERIMENTAL

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

Drug: Iopamidol

Interventions

Iopamidol DRUG

Contrast agent will be adrministered intravenously using total body weight or lean body weight, calculated with bioelectrical impedance analysis balance.

Also known as: Iomeprolo

LBW protocol; TBW protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

MeSH Terms

Interventions

Iopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiology

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: December 18, 2017
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)