Customized Contrast Media Dose Clinical Trial

Clinical Trial of a Novel Evidence-Based Formula for Customizing the Contrast Media Dose and Rate Administered During Multidetector-Row CT (MDCT) Scanning of the Abdomen and Pelvis

1. To determine if a formula derived from PCA using specific patient parameters can be used to determine the individual contrast material dose and provide a more consistent level of vascular and parenchymal enhancement during MDCT scanning of the abdomen and pelvis.
2. Up to 500 adult patients referred for a "CT of the abdomen and pelvis with contrast material" will be recruited to participate in this trial. Single CT axial slices (n=2) will be obtained at the level of the L4 pedicle and the supra-acetabular pelvis using a field-of-view that includes all of the patient. From patient measurements (height, weight, body dimensions), a customized dose of contrast material will be specified according to the derived formula for 400 subjects. One hundred subjects will receive the usual fixed contrast dose.
3. Enhancement data in HU will be measured from the CT scans using manually-placed ROIs on the upper abdominal aorta, main portal vein and liver parenchyma, avoiding visible liver tumors, major blood vessels and artifacts, if present. This enhancement data will be used to determine the patient-to-patient variability.

Study Overview

• Status: Terminated
• Conditions: CT of the Abdomen and Pelvis With Contrast Material
• Intervention / Treatment: Drug: Iopamidol; Device: Mydose

Detailed Description

The next step is a single center, prospective clinical trial intended to test the hypothesis that a formula derived from PCA using specific subject parameters can be used to determine the individual contrast material dose and provide a more consistent level of vascular and parenchymal enhancement during MDCT scanning of the abdomen and pelvis.

500 subjects referred for a "CT of the abdomen and pelvis with contrast material" will be recruited to participate in this trial. Subjects in the first group of 200 will be randomized to either a fixed dose of contrast material (100 subjects) or a customized dose of contrast material based on the experimental algorithm (100 subjects). The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm. All of the subjects will be studied on a single CT scanner located in the Duke Cancer Center. After obtaining informed consent, the subjects will first undergo measurement of their height and weight on a dedicated pair of scales located in close proximity to the scanner.

The subjects will then be placed on the CT scan table in the supine position followed by the acquisition of scout digital radiographs in both the AP and ML projections. These digital scout radiographs are acquired routinely and used by the technologist to plan the scan. From these scout radiographs, single CT slices in the axial plane (n=2) will subsequently be obtained, one through the level of the L4 pedicle and the other through the supra-acetabular pelvis using a field-of-view that includes all of the subject. These slices are not part of the routine protocol but will be acquired using low radiation dose parameters. From these measurements (height, weight and specific body dimensions), a customized dose of contrast material will be specified according to the derived formula. Since the dose will be different in every subject, the rate will need to be adjusted as well. This will be accomplished by adjusting the rate so that the injection duration is the same in every subject. For example, if the specified contrast material dose is 100 mL and the injection duration is 25 seconds, the injection rate will be 4 mL/sec. If the specified contrast material dose is 125 mL and the injection duration is also 25 seconds, the injection rate will be increased to 5 mL/sec. Note that 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine) and. Also note that for the customized dose group, the maximum and minimum doses of contrast material will be 200 (75 gm iodine) and 75 (22.5 gm iodine) mL, respectively and the maximum and minimum injection rates will be 6 and 2 mL/sec, respectively. Because the injection rate in the customized group is variable, the nurse or technologist establishing intravenous access may choose to use a larger or small caliber angiocatheter than in the fixed group in order to accommodate a higher or lower injection rate, respectively. The caliber of the angiocatheter as well as the venous access site will be recorded along with the dose and rate of contrast material. The rate of administration of contrast material is controlled by a mechanical power injector furnished by Nemoto Kyorindo Co, Ltd. free of charge for use in this study.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Duke University Medical Center

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:

• Patients referred for a CT of the Abdomen & Pelvis with Contrast Material

Exclusion Criteria:

• Younger than 18
• Pregnant
• Contraindication of iodinated contrast material
• Contraindication to a bolus injection
• Indication for biphasic exam (arterial + venous phases)
• Diffuse hepatic disease
• Subjects weighing more than 300 pounds

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fixed dose; 100 of the first 200 subjects will be randomized to a fixed dose of contrast material.	Drug: Iopamidol; Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
Active Comparator: Customized dose; 100 of the first 200 subjects will be randomized to a customized dose of contrast material based on the experimental algorithm. The second group of 300 subjects will receive a customized dose of contrast material based on the experimental algorithm.	Drug: Iopamidol; Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).; Device: Mydose; 400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variability in Enhancement Data, Measured in Hounsfield Units (HU)	During CT scan, approximately 5 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Nemoto Kyorindo Co, Ltd.
• Investigators: Principal Investigator: Daniele Marin, MD, Duke University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 6, 2016
• Study Completion (Actual): October 6, 2016

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Pro00059984

Drug and device information, study documents

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