VolUS3D: Volume 3D_US Kidney

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT03841149
Collaborator
(none)
80
1
39
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ultrasound Imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Measurement of Kidney Volume and Renal Tumor Volume Using 3D-Ultrasound Imaging
Actual Study Start Date :
Jun 29, 2020
Anticipated Primary Completion Date :
Sep 29, 2023
Anticipated Study Completion Date :
Sep 29, 2023

Arms and Interventions

Arm Intervention/Treatment
VolUS3D patients

Patients with renal tumour

Other: Ultrasound Imaging
3D volume calculation using on-line and off-line softwares
Other Names:
  • 3D Ultrasound transducer and fusion imaging
  • Outcome Measures

    Primary Outcome Measures

    1. 3D-US volume measurements [1 month]

      Kidney and renal tumor

    Secondary Outcome Measures

    1. 2D-US volume measurements [1 month]

      Kidney and renal tumor

    2. Inter and intra variability measurements [1 month]

      Kidney and renal tumor

    3. 2D and 3D US volume measurements during Contrast-enhanced US (if performed for patient management) [1 month]

      Kidney and renal tumor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Necker-Enfants Malades Paris France 75015

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Jean-Michel Correas, PU-PH, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT03841149
    Other Study ID Numbers:
    • NI18037J
    • 2018-A01394-51
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Dec 23, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 23, 2021