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| Name | Class |
|---|---|
| Oslo Metropolitan University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Half iodine - Spectral CT group | Experimental | Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 kiloelectronVolts (keV). |
|
| Standard iodine - Conventional CT | Active Comparator | Patients receive standard dosage of iodine contrast agent, and conventional 120 kiloVolts (kV) polychromatic CT images |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Half iodine Spectral CT | Diagnostic Test | Patients receive half dosage of iodine contrast agent, and Spectral CT acquisition with Virtual Monoenergetic Images at 40 and 50 keV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial attenuation | 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. | Measured on CT images acquired at time of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective examination quality | Examination quality rated by interventional radiologists on a 4-point scale at the anatomic levels: aorta, common iliac, femoral, popliteal- and calf arteries. Subjective examination quality rating scale:
|
| Measure | Description | Time Frame |
|---|---|---|
| Image noise | Image noise was defined as the standard deviation of arterial attenuation measurements (see outcome 1) measured in HU digitally by placing a ROI on the CT-images in the aorta, common iliac-, femoral- and popliteal arteries. | Measured on CT-images acquired at time of inclusion |
| Contrast to noise ratio (CNR) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter M Lauritzen, MD PhD | University Hospital, Akershus & Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Akershus | 1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37071166 | Derived | Kristiansen CH, Thomas O, Tran TT, Roy S, Hykkerud DL, Sanderud A, Geitung JT, Lauritzen PM. Halved contrast medium dose in lower limb dual-energy computed tomography angiography-a randomized controlled trial. Eur Radiol. 2023 Sep;33(9):6033-6044. doi: 10.1007/s00330-023-09575-3. Epub 2023 Apr 18. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2022 | Jun 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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RCT: Patients assigned to study or control group
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Participants are not informed of which arm they are assigned to.
| Standard iodine conventional CT | Diagnostic Test | Patients receive standard dosage of iodine contrast agent, and conventional 120 kv Polychromatic CT acquisition. |
|
| Rated on CT images acquired at time of inclusion |
| Rate of diagnostic quality angiography | Based on measurements of attenuation in the aorta, common iliac-, femoral- and popliteal arteries. Diagnostic quality defined as arterial attenuation >200 Hounsfield units (HU) | Measured on images acquired at time of inclusion |
Contrast to noise ratio was defined as: (Arterial attenuation - Background attenuation) / Image noise Arterial attenuation: (see outcome 1) measured in HU digitally by placing a ROI on the CT-images in the aorta, common iliac-, femoral- and popliteal arteries. Background attenuation: defined as attenuation in muscle measured in HU digitally by placing an identical size ROI on the CT-images in muscle tissue at the same anatomical levels as the arterial measurements. Image noise: see outcome 4 |
| Measured on CT-images acquired at time of inclusion |
| Signal to noise ratio (SNR) | Signal to noise ratio was defined as: Arterial attenuation / Image noise Arterial attenuation: (see outcome 1) measured in HU digitally by placing a ROI on the CT-images in the aorta, common iliac-, femoral- and popliteal arteries. Image noise: see outcome 4 | Measured on CT-images acquired at time of inclusion |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |