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Completed

NCT Number: NCT03841149

Volume 3D_US Kidney

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.

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Key information

Conditions

Chronic Kidney Diseases Adenocarcinoma Carcinoma Carcinoma, Renal Cell Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Tumor Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound imaging

Other

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

Other names: 3D Ultrasound transducer and fusion imaging

Primary outcomes

  1. 3D-US volume measurements

    Time frame: 1 month

    Kidney and renal tumor

Secondary outcomes

  1. 2D-US volume measurements

    Time frame: 1 month

    Kidney and renal tumor

  2. Inter and intra variability measurements

    Time frame: 1 month

    Kidney and renal tumor

  3. 2D and 3D US volume measurements during Contrast-enhanced US (if performed for patient management)

    Time frame: 1 month

    Kidney and renal tumor

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: VolUS3D

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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