Multiparametric MRI for Diagnosing Small Renal Tumors

NCT03470285 | Completed

• 1 other identifier: CHUBX 2015/40
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Renal Cancer

Keywords

Mulitparametric MR Imaging; Small solid renal tumors

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of multiparametric MR imaging (mpMRI)

  Index test will be the result from a dichotomized Likert Scale assessing the level of certainty of the malignant of benign nature as assessed by the radiologist on mpMRI images. The reference standard will be the pathology of the tumor (biopsy or surgery). The main measure of interest is the negative predictive value of a dichotomized Likert scale that is rating the level of certainty of the tumor nature diagnosis, based on mpMRI.

  For MRI results change from 1 day after urologist consultation up to 75 days, for pathology results change from 75 days after urologist consultation up to 3 months

Secondary Outcomes (6)

• Impact of mpMRI on the clinical management of renal tumors

  For MDC 1 up to 45 days after first urologist consultation, for MDC 2 up to 75 days after first urologist consultation

• Inter-observer reproducibility of mpMRI

  At inclusion

• MR parameters in tumor subgroups based on histological findings

  For MRI results between from 1 day after urologist consultation up to 75 days, for pathology results from 75 days after urologist consultation up to 3 months

• Conclusion about the aggressiveness of clear cell renal cell carcinoma as assessed either by MR parameters or according to Fuhrman grade

  For MRI results between from 1 day after urologist consultation up to 75 days, for pathology results from 75 days after urologist consultation up to 3 months

• Occurrence of adverse events up to 6 months after mpMRI, initial surgery, biopsy or ablation

  From inclusion up to 6 months

Study Arms (1)

Patients with small solid renal tumor

OTHER

In addition to the actual workflow for a patient presenting a renal tumor, patients will undergo an additional Multiparametric MR imaging (mpMRI).

Procedure: Multiparametric MR imaging (mpMRI)

Interventions

Multiparametric MR imaging (mpMRI) PROCEDURE

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.

Patients with small solid renal tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18;
• Performance Index ≤ 2 (WHO);
• Non hereditary solid renal tumors;
• Indication of renal surgery or renal biopsy for suspicion of malignancy of the tumor
• Size of renal mass between 1,5 and 4 cm;
• Single Renal mass;
• Discovered incidentally by US and / or CT-scan;
• IRMK01 and UroCCR Informed consents signed.
• Affiliated or beneficiary of French social security
• All women of childbearing potential must have effective contraception from the time of screening until MRI. Acceptable methods of contraception include combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable) intrauterine device, intrauterine hormonereleasing system, bilateral tubal occlusion, vasectomized partner and sexual abstinence

You may not qualify if:

• Patent signs of malignancy (metastasis, lymphadenopathy, thrombus ...);
• Cystic lesions according to the Bosniak classification;
• Lesions with macroscopic fat on ultrasound or CT-scan;
• Multiple or bilateral renal tumors;
• Histological evidence available initially;
• History of renal neoplasia whatever the location or family context (Von Hippel Lindau, Bourneville sclerosis);
• Moderate to terminal renal impairment documented (creatinine clearance \<30 mL / min according MDRD or CKD-EPI);
• Impossibility to perform MRI :
• heart pacemakers (especially older types)
• insulin pumps
• implanted hearing aidsIRMK01 Version no.3.0 of 28/10/2020 Page 12 of 83
• neurostimulators
• intracranial metal clips
• metallic bodies in the eye
• Contraindication to gadolinium salt.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (18)

CHU Angers

Angers, 49933, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

APHP - Henri Mondor

Créteil, 94010, France

Location

CHU de Grenoble

Grenoble, France

Location

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

CHRU Lille

Lille, 59000, France

Location

CHU Lyon

Lyon, 69444, France

Location

APHM - Hôpital de la Conception

Marseille, 13385, France

Location

CHU Nancy

Nancy, 54511, France

Location

CHU Nice

Nice, 06001, France

Location

APHP - Hôpital Tenon

Paris, 75020, France

Location

APHP - Hôpital Necker

Paris, 75743, France

Location

APHP - Hôpital Bichat

Paris, France

Location

CHU Rennes

Rennes, 35033, France

Location

CHU Rouen

Rouen, 76031, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

CHU Toulouse

Toulouse, 31062, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (2)

• Galmiche C, Bernhard JC, Yacoub M, Ravaud A, Grenier N, Cornelis F. Is Multiparametric MRI Useful for Differentiating Oncocytomas From Chromophobe Renal Cell Carcinomas? AJR Am J Roentgenol. 2017 Feb;208(2):343-350. doi: 10.2214/AJR.16.16832. Epub 2016 Dec 13.

  PMID: 27959744 RESULT

• Cornelis F, Grenier N. Multiparametric Magnetic Resonance Imaging of Solid Renal Tumors: A Practical Algorithm. Semin Ultrasound CT MR. 2017 Feb;38(1):47-58. doi: 10.1053/j.sult.2016.08.009. Epub 2016 Sep 1.

  PMID: 28237280 RESULT

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

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: February 26, 2018
• First Posted: March 19, 2018
• Study Start: November 27, 2018
• Primary Completion: May 27, 2022
• Study Completion: April 14, 2023
• Last Updated: May 14, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (18)