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Volume 3D_US Kidney (VolUS3D)

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ClinicalTrials.gov Identifier: NCT03841149
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
Chronic Kidney Diseases Renal Tumor 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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Kidney Volume and Renal Tumor Volume Using 3D-Ultrasound Imaging
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
VolUS3D patients
Patients with renal tumour
Other: Ultrasound Imaging
3D volume calculation using on-line and off-line softwares
Other Name: 3D Ultrasound transducer and fusion imaging




Primary Outcome Measures :
  1. 3D-US volume measurements [ Time Frame: 1 month ]
    Kidney and renal tumor


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients (n=80) referred for renal tumour management (including imaging, biopsy or percutaneous ablation)
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841149


Contacts
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Contact: Jean-Michel Correas, PU-PH +33 1 44 49 41 40 jean-michel.correas@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
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France
Hôpital Necker-Enfants Malades Not yet recruiting
Paris, France, 75015
Contact: Jean-Michel Correas, PU-PH    +33 1 44 49 41 40    jean-Michel.correas@aphp.fr   
Contact: Hélène Morel    +33 1 71 1963 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Michel Correas, PU-PH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03841149     History of Changes
Other Study ID Numbers: NI18037J
2018-A01394-51 ( Other Identifier: N° ID-RCB )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
3D Ultrasound volume measurements
Renal volume
Tumour Volume
Additional relevant MeSH terms:
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Kidney Neoplasms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms