Volume 3D_US Kidney

Chronic Kidney Diseases Clinical Trial

— VolUS3D  

Official title:

Measurement of Kidney Volume and Renal Tumor Volume Using 3D-Ultrasound Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841149
• Other study ID #: NI18037J
• Secondary ID: 2018-A01394-51
• Status: Completed
• Start date: June 29, 2020
• Est. completion date: September 11, 2023

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 11, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Kidney Neoplasms
• Renal Insufficiency, Chronic
• Renal Tumor

Intervention

Other:
• Ultrasound Imaging
3D volume calculation using on-line and off-line softwares

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D-US volume measurements	Kidney and renal tumor	1 month
Secondary	2D-US volume measurements	Kidney and renal tumor	1 month
Secondary	Inter and intra variability measurements	Kidney and renal tumor	1 month
Secondary	2D and 3D US volume measurements during Contrast-enhanced US (if performed for patient management)	Kidney and renal tumor	1 month