CT TAVR Abdomen Study

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05758701

Collaborator

(none)

164

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.

Condition or Disease	Intervention/Treatment	Phase
Transcatheter Aortic Valve Replacement	Combination Product: Iodinated Contrast Agent (Omnipaque) Device: Dual Energy CT	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

In a standard polyenergetic CT procedure, 100 ml of iodinated contrast is used. Two cohorts of patients will be assessed, the first being given a 1/3rd reduction (33 ml). If satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If unsatisfactory, the IV contrast dose will be increased to 1/2 (50 ml)In a standard polyenergetic CT procedure, 100 ml of iodinated contrast is used. Two cohorts of patients will be assessed, the first being given a 1/3rd reduction (33 ml). If satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If unsatisfactory, the IV contrast dose will be increased to 1/2 (50 ml)

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).	Combination Product: Iodinated Contrast Agent (Omnipaque) Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage. Device: Dual Energy CT Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.
Experimental: Cohort 2 If imaging with 1/3 dose is satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If images are not satisfactory, contrast dose will be increased to 50 ml.	Combination Product: Iodinated Contrast Agent (Omnipaque) Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage. Device: Dual Energy CT Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.

Arm

Intervention/Treatment

Experimental: Cohort 1

A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).

Combination Product: Iodinated Contrast Agent (Omnipaque)

Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage.

Device: Dual Energy CT

Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.

Experimental: Cohort 2

If imaging with 1/3 dose is satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If images are not satisfactory, contrast dose will be increased to 50 ml.

Combination Product: Iodinated Contrast Agent (Omnipaque)

Standard dosage of Omnipaque for CT imaging is 100 ml. Cohort will be given a reduced dosage.

Device: Dual Energy CT

Dual energy CT scanners enable monoenergetic CT image reconstruction which allows for improved iodine image contrast.

Outcome Measures

Primary Outcome Measures

Diagnostic Quality of Images [18-24 months]
5-point Likert Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 88 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

scheduled to receive TAVR abdominal CT

Exclusion Criteria:

cannot undergo CT scan
Allergy to intravenous contrast not controlled by steroids or benadryl
GFR<30

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Medical Center	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Vikas Kundra, Chief of Oncologic Imaging, Dept. of Radiology and Nuclear Medicine, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT05758701

Other Study ID Numbers:

HP-00104800

First Posted:

Mar 7, 2023

Last Update Posted:

Mar 7, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Vikas Kundra, Chief of Oncologic Imaging, Dept. of Radiology and Nuclear Medicine, University of Maryland, Baltimore

Dual energy CT

Study Results

No Results Posted as of Mar 7, 2023