Volume 3D_US Kidney

Completed

• Conditions: Renal Tumor; Chronic Kidney Diseases
• Interventions: Other: Ultrasound Imaging

• Registration Number: NCT03841149
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of this study is to measure the volume of the kidney and tumors using 3D-US acquisition and to correlate these measurements to contrast-enhanced CT or MRI.

Detailed Description

Additional objectives are comparison between true volume measurements and volume estimation using measurements of the three perpendicular diameters, comparison of inter and intra variability of 3D US measurements with inter and intra variability of 3D CT or MRI measurements, calculation of 3D and 2D volume measurements during contrast-enhanced US examination when the injection is performed for clinical routine purposes such as vascular and extension staging, during interventional procedures such as US guided biopsy targeting the non-necrotic tumour parenchyma. Concordance between 2D and 3D US acquisitions will be compared to CT and MRI measurements. Comparison of volume measurements between non-contrast and contrast-enhanced methods (US, CT and MRI) will be performed. The results will be compared to renal function before and after tumour treatment.

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2020-06-29
• Primary Completion: 2023-09-11
• Study Completion: 2023-09-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Adult patient (age 18)
• Absence of participant's opposition
• No contra-indication to contrast-enhanced CT AND MRI (a single contrast-enhanced imaging modality is sufficient)
• Affiliated to Social Security

Exclusion Criteria

• Contra-indication to both contrast-enhanced CT AND MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VolUS3D patients	Ultrasound Imaging	Patients with renal tumour

Primary Outcome Measures

Name	Time	Method
3D-US volume measurements	1 month	Kidney and renal tumor

Secondary Outcome Measures

Name	Time	Method
2D-US volume measurements	1 month	Kidney and renal tumor
Inter and intra variability measurements	1 month	Kidney and renal tumor
2D and 3D US volume measurements during Contrast-enhanced US (if performed for patient management)	1 month	Kidney and renal tumor

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France