Magnetic Resonance Imaging (MRI)UUTICaDNCT07252882
Interest of Magnetic Resonance Imaging in the Diagnosis of Upper Urinary Tract Invasive Tumours
A study testing Upper urinary tract magnetic resonance imaging in people with Magnetic Resonance Imaging (MRI) and Urologic Cancer, run by University Hospital, Toulouse at 11 sites in France.
Trial summary
Upper urinary tract invasive cancer magnetic resonance imaging diagnosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging (MRI), Urologic Cancer
- What is being tested?
- Upper urinary tract magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites
Hôpital Pellegrin
Bordeaux, France, 33000
Eva JAMBON, MD, 0557820846 ext. 33, eva.jambon@chu-bordeaux.fr
Eva JAMBON, MD
Hôpital Claude Huriez
Lille, France, 59037
Gautier MARCQ, MD, 0320444202 ext. 33, gautier.marq@chu-lille.fr
Gautier MARCQ, MD, PhD
Institut Paoli Calmettes
Marseille, France, 13009
Géraldine PIGNOT LEQUEUX, MD, 0617174950 ext. 33, pignotg@ipc.unicancer.fr
Géraldine PIGNOT LEQUEUX, MD
Clinique Beau Soleil
Montpellier, France, 34070
Grégoire POINAS, MD, 0467456904 ext. 33, g.poinas@languedoc-mutualite.fr
Grégoire POINAS, MD
Hôpital Lapeyronie
Montpellier, France, 34295
Cécile MANCEAU, MD, 0677283524 ext. 33, cecile.manceau@chu-montpellier.fr
Cécile MANCEAU, MD
Hôpital Saint-Louis
Paris, France, 75010
Alexandra MASSON-LECOMTE, MD, PhD, 0142499615 ext. 33, alexandra.massonlecomte@aphp.fr
Alexandra MASSON-LECOMTE, MD, PhD
Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Thomas SEISEN, MD, 0673265693 ext. 33, thomas.seisen@aphp.fr
Thomas SEISEN, Md
Hôpital Européen Georges Pompidou
Paris, France, 75015
François AUDENET, MD, PhD, 0000 ext. 33, francois.audenet@aphp.fr
François AUDENET, MD, PhD
Clinique La Croix du Sud
Quint-Fonsegrives, France, 31130
Jacques ASSOUN, MD, 0615203690 ext. 33, jacques.assoun@wanadoo.fr
Jacques ASSOUN, MD
CHU de Toulouse
Toulouse, France, 31059
Thomas PRUDHOMME, MD, 0561322748 ext. 33, prudhomme.t@chu-toulouse.fr
Thomas PRUDHOMME, MD
Clinique Pasteur
Toulouse, France, 31076
Mathieu ROUMIGUIE, MD, PhD, 0561323229 ext. 33, roumiguie.m@chu-toulouse.fr
Mathieu ROUMIGUIE, MD, PhD
About this study
Upper urinary tract invasive cancer magnetic resonance imaging diagnosis
Read the 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.
- Conditions
- Magnetic Resonance Imaging (MRI), Urologic Cancer
- Being tested
- Upper urinary tract magnetic resonance imaging
- Keywords
- Upper urinary tract magnetic resonance imaging
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper urinary tract magnetic resonance imagingRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with upper urinary tract tumour | Experimental | Patients with upper urinary tract tumour and will have upper urinary tract magnetic resonance imaging Receives: Radiation: Upper urinary tract magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance Imaging (MRI)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252882
- Sponsor's protocol ID
- RC31/23/0389
- Acronym
- UUTICaD
- Status last verified
- Nov 2025
- First submitted
- 20 Jun 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Magnetic Resonance Imaging in the Diagnosis of Upper Urinary Tract Invasive Tumours
- ClinicalTrials.gov ID
- NCT07252882
- Acronym / sponsor ID
- UUTICaD / RC31/23/0389
- Conditions
- Magnetic Resonance Imaging (MRI), Urologic Cancer
- Keywords
- Upper urinary tract magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper urinary tract invasive cancer magnetic resonance imaging diagnosis
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with upper urinary tract tumour | Experimental | Radiation: Upper urinary tract magnetic resonance imagingPatients with upper urinary tract tumour and will have upper urinary tract magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper urinary tract magnetic resonance imagingPatients 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 | Radiation | Patients with upper urinary tract tumour |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper urinary tract magnetic resonance imaging in people with Magnetic Resonance Imaging (MRI) and Urologic Cancer, run by University Hospital, Toulouse at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas PRUDHOMME, MD (0561322748 ext. 33, prudhomme.t@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.