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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03841149
Other study ID # NI18037J
Secondary ID 2018-A01394-51
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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