CT TAVR Abdomen Study

Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05758701

Acronym

CT TAVR

Enrollment

164

Registered

2023-03-07

Start date

2023-09-19

Completion date

2028-03-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcatheter Aortic Valve Replacement

Keywords

Dual energy CT

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.

Interventions

COMBINATION_PRODUCTIodinated Contrast Agent (Omnipaque)

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

DEVICEDual Energy CT

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

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)

Eligibility

Sex/Gender

ALL

Age

18 Years to 88 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Quality of Images	18-24 months	5-point Likert Scale

Countries

United States

Contacts

CONTACTVikas Kundra, M.D., Ph.D

vkundra@som.umaryland.edu410-328-3477

CONTACTRosy Njonkou, M.S.

rnjonkou@som.umaryland.edu410-706-0943

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026