Ultra Low Iodine Loaded Spectral CT Angiography (CTA) of the Aorta and Lower Limb: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Mean arterial attenuation
Study Overview
Brief Summary
The objectives of this study are:
Evaluation of ultra-low iodine load CTA protocols of the aorta and lower extremities.
To investigate whether dual-layer in combination with with virtual monoenergetic imaging (VMI) allows for reduction of contrast medium (CM) in CTA of the aorta and lower limbs i with sustained objective and subjective image quality parameters.
Detailed Description
CT angiography (CTA) of the aorta and the lower limb is one of the most important tools for diagnostic, evaluation of the severity of the peripheral arterial disease, decision making, treatment planning and follow-up; but usually requires the use of iodine contrast medium.
Due to the high prevalence of renal impairment (eGFR < 90 ml/min/1.73m) in the elderly hospitalized population (more than 90% among inpatients aged over 60 years) contrast-medium-induced nephropathy is a major concern in this population.
The recently introduced spectral CT technique utilizes x-rays covering a spectrum of energy-levels as opposed to conventional CT in which x-rays are set to one specific energy level.
This technology offers many possibilities, such as "boosting" the x-ray contrast effect of iodine. This improves the vascular enhancement of the contrast medium using low-energy, virtual monoenergetic imaging (VNI).
The objectives of this study are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Masking Description
Participants are not informed of which arm they are assigned to.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of standard contrast dose (as calculated with the OmniVis calculator).
- •Patients with clinical suspicion of disease of the aorta and/or arteries in the lower limb.
- •Referral to CTA diagnosis, treatment planning or follow-up.
Exclusion Criteria
- •Iodine contrast medium allergy
- •Age < 18 years
- •Lack of informed consent
- •Critical ischemia of the lower extremities
Arms & Interventions
Half iodine - Spectral CT group
Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 kiloelectronVolts (keV).
Intervention: Half iodine Spectral CT (Diagnostic Test)
Standard iodine - Conventional CT
Patients receive standard dosage of iodine contrast agent, and conventional 120 kiloVolts (kV) polychromatic CT images
Intervention: Standard iodine conventional CT (Diagnostic Test)
Outcomes
Primary Outcomes
Mean arterial attenuation
Time Frame: Measured on CT images acquired at time of inclusion
Attenuation (x-ray density) is measured in Hounsfield units (HU) digitally by placing a "region of interest" (ROI) circle in the Aorta, common iliac-, femoral- and popliteal arteries on the CT images acquired at the time of inclusion.
Secondary Outcomes
- Subjective examination quality(Rated on CT images acquired at time of inclusion)
- Rate of diagnostic quality angiography(Measured on images acquired at time of inclusion)
Investigators
Peter Maehre Lauritzen
Researcher, Radiologist, PhD
University Hospital, Akershus