Interest of Magnetic Resonance Imaging in the Diagnosis of Upper Urinary Tract Invasive Tumours (UUTICaD)

November 26, 2025 updated by: University Hospital, Toulouse
Upper urinary tract invasive cancer magnetic resonance imaging diagnosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Urothelial tumours are the 6th most common cause of cancer in developed countries and occur throughout the urinary tract (urethra, bladder, ureter and pelvic cavities). Upper urinary tract tumours account for 5-10% of urothelial carcinomas. Nearly 60% of patients with upper urinary tract tumours are diagnosed as invasive (≥ T2). 90% of computed tomography lesions are tumour lesions. Currently, the diagnosis of upper urinary tract tumours is based on computed tomography with injection of nephrotoxic iodinated contrast medium (uro-computed tomography) and biopsies taken during ureteroscopy under general anaesthesia. Invasive tumours have a poor prognosis and patients with infiltrating tumours may benefit from neoadjuvant chemotherapy prior to nephroureterectomy (which may impair renal function). Uro-computed tomography cannot differentiate between invasive and non-invasive tumours and biopsies taken in the operating theatre during ureteroscopy under general anaesthesia are unreliable for staging and frequently underestimate the disease. The diagnosis of infiltrating tumours is most often made on nephro-ureterectomy specimens, making neoadjuvant treatment impossible. Recently, functional magnetic resonance imaging sequences (diffusion weighted imaging, apparent diffusion coefficient) highlighted the biophysical properties of the tissues such as cellular organisation, density and microcirculation and have thus made it possible to differentiate benign from malignant lesions by identifying the level of tissue involvement. Magnetic resonance imaging has become a real tool in the diagnosis of bladder tumours and can differentiate between infiltrating and non-infiltrating lesions.

The aim of this study is to make magnetic resonance imaging for each patient and compare results to pathological analysis (nephro-ureterectomy pathologic analysis or biopsy with 3 months Uro-computed tomography) to evaluate magnetic resonance imaging diagnosis capability for invasive tumour.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
178

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • France
      • Bordeaux, France, France, 33000
        • Hôpital Pellegrin
        • Contact:
        • Principal Investigator:
          • Eva JAMBON, MD
      • Lille, France, France, 59037
        • Hôpital Claude Huriez
        • Contact:
        • Principal Investigator:
          • Gautier MARCQ, MD, PhD
      • Marseille, France, France, 13009
        • Institut Paoli Calmettes
        • Contact:
        • Principal Investigator:
          • Géraldine PIGNOT LEQUEUX, MD
      • Montpellier, France, France, 34070
        • Clinique Beau Soleil
        • Contact:
        • Principal Investigator:
          • Grégoire POINAS, MD
      • Montpellier, France, France, 34295
      • Paris, France, France, 75010
        • Hôpital Saint-Louis
        • Contact:
        • Principal Investigator:
          • Alexandra MASSON-LECOMTE, MD, PhD
      • Paris, France, France, 75013
        • Hopital de La Pitie Salpetriere
        • Contact:
        • Principal Investigator:
          • Thomas SEISEN, Md
      • Paris, France, France, 75015
        • Hopital Europeen Georges Pompidou
        • Contact:
        • Principal Investigator:
          • François AUDENET, MD, PhD
      • Quint-Fonsegrives, France, France, 31130
        • Clinique la Croix du Sud
        • Contact:
        • Principal Investigator:
          • Jacques ASSOUN, MD
      • Toulouse, France, France, 31059
        • CHU de Toulouse
        • Contact:
        • Principal Investigator:
          • Thomas PRUDHOMME, MD
      • Toulouse, France, France, 31076
        • Clinique Pasteur
        • Contact:
        • Principal Investigator:
          • Mathieu ROUMIGUIE, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient over 18 years of age with a suspected upper urinary tract tumour based on the presence of a suspicious lesion on a uro-computed tomography scan
  • Have given free, informed and signed consent
  • Be affiliated to a social security scheme

Exclusion Criteria:

  • Renal failure not allowing the injection of iodinated contrast media (Glomerular filtration rate <30mL/min)
  • Subject under legal protection (guardianship or curatorship)
  • Pregnant or breastfeeding woman
  • Person participating in another research study or having participated in a protocol with an exclusion period still in progress at inclusion
  • Contraindication to magnetic resonance imaging (patient with non-magnetic resonance imaging compatible equipment, claustrophobia preventing magnetic resonance imaging)
  • Acide gadoteric hypersensibility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with upper urinary tract tumour
Patients with upper urinary tract tumour and will have upper urinary tract magnetic resonance imaging
Radiation: Upper urinary tract magnetic resonance imaging
Patients with a suspected malignant tumour of the upper urinary excretory tract based on the presence of a suspicious lesion on a uro-computed tomography scan will have a diagnostic magnetic resonance imaging of the urinary tract with Gadolinium-based contrast agents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic validity (composite criteria sensitivity and specifcity) of a predefined magnetic resonance imaging sequence in the diagnosis of upper urinary tract invasive tumour
Time Frame: 3 months
Diagnostic validity (sensitivity and specifcity) of a predefined magnetic resonance imaging sequence in the diagnosis of upper urinary tract invasive tumour (taking as reference the pathological analysis [gold standard] or biopsy with 3 months Uro-CT).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/23/0389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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