Volume 3D_US Kidney

NCT ID: NCT03841149

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-29

Study Completion Date

2023-09-11

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases Renal Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VolUS3D patients

Patients with renal tumour

Ultrasound Imaging

Intervention Type OTHER

3D volume calculation using on-line and off-line softwares

Interventions

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Ultrasound Imaging

3D volume calculation using on-line and off-line softwares

Intervention Type OTHER

Other Intervention Names

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3D Ultrasound transducer and fusion imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Michel Correas, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Necker-Enfants Malades

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2018-A01394-51

Identifier Type: OTHER

Identifier Source: secondary_id

NI18037J

Identifier Type: -

Identifier Source: org_study_id

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