Ultra Low Iodine Loaded Spectral CT Angiography (CTA)

University Hospital, Akershus

Status: Completed

Conditions: Renal Insufficiency; Peripheral Arterial Disease

Treatments: Diagnostic Test: Half iodine Spectral CT; Diagnostic Test: Standard iodine conventional CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05488899

2018_070

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Half iodine - Spectral CT group

Experimental group

Description:

Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 kiloelectronVolts (keV).

Treatment:

Diagnostic Test: Half iodine Spectral CT

Standard iodine - Conventional CT

Active Comparator group

Description:

Patients receive standard dosage of iodine contrast agent, and conventional 120 kiloVolts (kV) polychromatic CT images

Treatment:

Diagnostic Test: Standard iodine conventional CT