NCT07252882

Brief Summary

Upper urinary tract invasive cancer magnetic resonance imaging diagnosis

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
not yet recruiting

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

Study Progress21%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

June 20, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

June 20, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

Upper urinary tract magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Diagnostic validity (composite criteria sensitivity and specifcity) of a predefined magnetic resonance imaging sequence in the diagnosis of upper urinary tract invasive tumour

    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

Study Arms (1)

Patients with upper urinary tract tumour

EXPERIMENTAL

Patients with upper urinary tract tumour and will have upper urinary tract magnetic resonance imaging

Radiation: Upper urinary tract magnetic resonance imaging

Interventions

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

Patients with upper urinary tract tumour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Contraindication to magnetic resonance imaging (patient with non-magnetic resonance imaging compatible equipment, claustrophobia preventing magnetic resonance imaging)
  • Acide gadoteric hypersensibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital Pellegrin

Bordeaux, France, 33000, France

Location

Hôpital Claude Huriez

Lille, France, 59037, France

Location

Institut Paoli Calmettes

Marseille, France, 13009, France

Location

Clinique Beau Soleil

Montpellier, France, 34070, France

Location

Hôpital Lapeyronie

Montpellier, France, 34295, France

Location

Hôpital Saint-Louis

Paris, France, 75010, France

Location

Hôpital de la Pitié Salpêtrière

Paris, France, 75013, France

Location

Hôpital Européen Georges Pompidou

Paris, France, 75015, France

Location

Clinique La Croix du Sud

Quint-Fonsegrives, France, 31130, France

Location

CHU de Toulouse

Toulouse, France, 31059, France

Location

Clinique Pasteur

Toulouse, France, 31076, France

Location

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases

Central Study Contacts

Thomas PRUDHOMME, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2025

First Posted

November 28, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations