NCT03841149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 29, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

3.2 years

First QC Date

February 12, 2019

Last Update Submit

September 8, 2025

Conditions

Chronic Kidney DiseasesRenal Tumor

Keywords

3D Ultrasound volume measurementsRenal volumeTumour Volume

Outcome Measures

Primary Outcomes (1)

  • 3D-US volume measurements

    Kidney and renal tumor

    1 month

Secondary Outcomes (3)

  • 2D-US volume measurements

    1 month

  • Inter and intra variability measurements

    1 month

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

    1 month

Study Arms (1)

VolUS3D patients

Patients with renal tumour

Other: Ultrasound Imaging

Interventions

Ultrasound ImagingOTHER

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

Also known as: 3D Ultrasound transducer and fusion imaging
VolUS3D patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (n=80) referred for renal tumour management (including imaging, biopsy or percutaneous ablation)

You may qualify if:

  • 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

You may not qualify if:

  • \- Contra-indication to both contrast-enhanced CT AND MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicCarcinoma, Renal Cell

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Jean-Michel Correas, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 15, 2019

Study Start

June 29, 2020

Primary Completion

September 11, 2023

Study Completion

September 11, 2023

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)