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Customized Contrast Media Dose Clinical Trial

NCT02433665 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2020-06-16

Study results available
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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.

Conditions

  • CT of the Abdomen and Pelvis With Contrast Material

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Daniele Marin, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-10-06
Completion
2016-10-06
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433665 on ClinicalTrials.gov