Customized Contrast Media Dose Clinical Trial

NCT ID: NCT02433665

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-10-06

Brief Summary

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.

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.

Conditions

CT of the Abdomen and Pelvis With Contrast Material

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fixed dose

100 of the first 200 subjects will be randomized to a fixed dose of contrast material.

Group Type: ACTIVE_COMPARATOR

Iopamidol

Intervention Type: DRUG

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).

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.

Group Type: ACTIVE_COMPARATOR

Iopamidol

Intervention Type: DRUG

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).

Mydose

Intervention Type: DEVICE

400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters.

Interventions

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).

Intervention Type: DRUG

Mydose

400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemoto Kyorindo Co, Ltd.

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniele Marin, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00059984

Identifier Type: -

Identifier Source: org_study_id