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COMPLETED
NCT03470285
NA

Multiparametric MRI for Diagnosing Small Renal Tumors

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

Renal cell carcinoma represents annually 3-5% of all new cancer diagnoses. To date, the standard of care for small renal masses is partial nephrectomy. However, in the specific setting of small renal masses, 20% of them are benign and surgery results in overtreatment. Non-invasive techniques able to differentiate the inherent characteristics of tumors (nature, aggressiveness) would be useful to offer the most appropriate therapeutic options. Morphological ultrasound or CT imaging appeared limited because of the lack of discriminatory power. Based on the data of retrospective studies, the hypothesis is that multiparametric (mp) MR parameters using chemical shift, diffusion and/or contrast injection techniques may be a reproducible diagnostic test with sufficient diagnostic accuracy to differentiate benign from malignant renal tumors. The originality of this project lies in the opportunity to simultaneously assess the performance of mpMRI in diagnosing renal tumors in a routine clinical practice in 18 centers. In each center, two independent MRI readings performed by two radiologists will be carried out within a short delay and interpreted blind to each other's results or pathological results using a predefined template. A third reading will also be centrally performed by the coordinating center according to similar modality. All clinical, radiological and pathological data will be collected after anonymization in the UroCCR database. These informations are used to adjust the therapeutic decision and selecting patients eligible for nephrectomy, other therapeutic options or monitoring.

Official title: Diagnostic Value of Multiparametric MR Imaging of Small Solid Renal Tumors (IRMK01)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

387

Start Date

2018-11-27

Completion Date

2023-04-14

Last Updated

2026-05-14

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Multiparametric MR imaging (mpMRI)

The main objective of the study is to assess the diagnostic accuracy of mpMRI in small renal tumors. The study characteristics will comply with recommended methods (Quadas, Stard). The population to be included will be representative of patients who would benefit from mpMRI if it is demonstrated to be accurate. In this project, the MR protocol will used the conventional MR sequences either on 1.5 or 3T systems and do not require development. Each center may use their own protocol as long as it includes the mandatory sequences.

Locations (18)

CHU Angers

Angers, France

CHU Bordeaux

Bordeaux, France

APHP - Henri Mondor

Créteil, France

CHU de Grenoble

Grenoble, France

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, France

CHRU Lille

Lille, France

CHU Lyon

Lyon, France

APHM - Hôpital de la Conception

Marseille, France

CHU Nancy

Nancy, France

CHU Nice

Nice, France

APHP - Hôpital Tenon

Paris, France

APHP - Hôpital Necker

Paris, France

APHP - Hôpital Bichat

Paris, France

CHU Rennes

Rennes, France

CHU Rouen

Rouen, France

CHU Strasbourg

Strasbourg, France

CHU Toulouse

Toulouse, France

CHU Tours

Tours, France