CT TAVR Abdomen Study

NCT05758701 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HP-00104800
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Replacement

Keywords

Dual energy CT

Outcome Measures

Primary Outcomes (1)

• Diagnostic Quality of Images

  5-point Likert Scale

  18-24 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Combination Product: Iodinated Contrast Agent (Omnipaque); Device: Dual Energy CT

Cohort 2

EXPERIMENTAL

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); Device: Dual Energy CT

Interventions

Iodinated Contrast Agent (Omnipaque) COMBINATION_PRODUCT

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

Cohort 1; Cohort 2

Dual Energy CT DEVICE

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

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled to receive TAVR abdominal CT

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (2)

• Schoenhagen P, Hausleiter J, Achenbach S, Desai MY, Tuzcu EM. Computed tomography in the evaluation for transcatheter aortic valve implantation (TAVI). Cardiovasc Diagn Ther. 2011 Dec;1(1):44-56. doi: 10.3978/j.issn.2223-3652.2011.08.01.

  PMID: 24282684 BACKGROUND

• Gurm HS, Dixon SR, Smith DE, Share D, Lalonde T, Greenbaum A, Moscucci M; BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) Registry. Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol. 2011 Aug 23;58(9):907-14. doi: 10.1016/j.jacc.2011.05.023.

  PMID: 21851878 BACKGROUND

MeSH Terms

Interventions

Iohexol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Vikas Kundra, M.D., Ph.D

CONTACT

410-328-3477; vkundra@som.umaryland.edu

Rosy Njonkou, M.S.

CONTACT

410-706-0943; rnjonkou@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Oncologic Imaging, Dept. of Radiology and Nuclear Medicine

Model Details: 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)

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 7, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)