Customized Contrast Media Dose Clinical Trial

NCT02433665 | Terminated Results FDA Drug FDA Device

• 1 other identifier: Pro00059984
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Variability in Enhancement Data, Measured in Hounsfield Units (HU)

  During CT scan, approximately 5 minutes

Study Arms (2)

Fixed dose

ACTIVE COMPARATOR

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

Drug: Iopamidol

Customized dose

ACTIVE COMPARATOR

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; Device: Mydose

Interventions

Iopamidol 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; Fixed dose

Mydose DEVICE

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

Customized dose

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Nemoto Kyorindo Co, Ltd.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27713, United States

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

Results Point of Contact

• Title: Dr. Daniele Marin
• Organization: Duke University Medical Center

daniele.marin@duke.edu

919.684.7709

Study Officials

• Daniele Marin, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 5, 2015
• Study Start: August 1, 2015
• Primary Completion: October 6, 2016
• Study Completion: October 6, 2016
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-05

Locations

US (1)