Virtual Monoenergetic Imaging of the Lower Extremities Using Dual-Energy CT Angiography in Patients with Diabetes Mellitus: A Randomized Controlled Trial

Virtual Monoenergetic Imaging of the Lower Extremities Using Dual-Energy CT Angiography in Patients with Diabetes Mellitus: A Randomized Controlled Trial - DECTA of lower extremities in patients with DM: RCT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57087

Enrollment

135

Registered

2024-11-05

Start date

2025-05-02

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Diabetes peripheral vascular disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adult patients (aged 18 years and above). - Confirmed diagnosis of diabetes mellitus and critical limb ischemia (Rutherford classification stage 4 and higher) - Scheduled for lower extremity CTA for suspected arterial disease. - Signed informed consent papers

Exclusion criteria

Exclusion criteria: - Severe renal impairment (glomerular filtration rate

Design outcomes

Primary

Measure	Time frame
Primary endpoints are scores on image quality, image noise and vessel contrast on a 5 point scale (see chapter 3, table 1 of our research protocol) on both dual energy CTA and conventional CTA. Two experienced radiologists will score the CT-images.	—

Secondary

Measure	Time frame
- Secondary endpoints are signal to noise ratio (SNR) and contrast to noise ratio (CNR). Attenuation values (HU) and standard deviation (SD) are quantified in lower leg arteries, subcutaneous fat and iliopsoas muscle in both DECTA and conventional CTA by a radiologist. The following formula is used to determine SNR and CNR: SNR=(HU,artery)/(SD,fat) CNR=((HU,artery-HU,muscle))/(SD,fat) - Total radiation dose will be automatically quantified by the CT-scan - To evaluate the diagnostic accuracy of DECTA and conventional CTA in detecting stenosis or occlusions in the lower legs compared to DSA as gold standard; assessed by sensitivity, specificity, and area under the receiver operating characteristic curve. This will be subgroup analysis, performed in participants who had a DSA within 60 days of their CTA as part of standard care.	—

Measure

Time frame

- Secondary endpoints are signal to noise ratio (SNR) and contrast to noise ratio (CNR). Attenuation values (HU) and standard deviation (SD) are quantified in lower leg arteries, subcutaneous fat and iliopsoas muscle in both DECTA and conventional CTA by a radiologist. The following formula is used to determine SNR and CNR: SNR=(HU,artery)/(SD,fat) CNR=((HU,artery-HU,muscle))/(SD,fat) - Total radiation dose will be automatically quantified by the CT-scan - To evaluate the diagnostic accuracy of DECTA and conventional CTA in detecting stenosis or occlusions in the lower legs compared to DSA as gold standard; assessed by sensitivity, specificity, and area under the receiver operating characteristic curve. This will be subgroup analysis, performed in participants who had a DSA within 60 days of their CTA as part of standard care.

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Countries

Netherlands

Outcome results