Multiparametric MRI for Diagnosing Small Renal Tumors (IRMK01)

May 11, 2026 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Renal cell carcinoma represents annually 3-5% of all new cancer diagnoses. In France, its incidence is about 10,000 cases/year. It has been increasing for the past thirty years, probably related to incidental imaging findings. The average age of diagnosis is 65 years. Although the mortality rate started to decrease, partly due to an earlier diagnosis, the overall survival at 5 years is 63% but significantly higher for localized stages (58% of diagnoses): 90%. 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. Moreover, for selected patients with comorbidities and potentially low risk tumors, a surveillance strategy can be offered. No preoperative image based tumor characterization has been validated so far, and the kidney tumor biopsy is currently the only way to rule out patients for overtreatment. However, kidney tumor biopsy is invasive, time-consuming, sometimes inconclusive, especially in case of small size tumors, and its low accuracy in predicting tumor aggressiveness based on the Fuhrman grade was several times reported in the literature. Kidney tumor biopsy results may also be impacted by the intra-tumoral heterogeneity. Thus, non-invasive techniques able to differentiate the inherent characteristics of tumors would be useful to offer the most appropriate therapeutic options. Morphological ultrasound or CT imaging appear limited because of the lack of discriminatory power between the different tumor subtypes. Based on the data of retrospective studies, the hypothesis is that 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 tumors and better estimate the tumor aggressiveness. To date, no prospective multi-center study on multiparametric (mp) MR imaging of renal tumors has been reported. Although CT-scan explorations are the standard of care in case of renal tumors, MRI offers several advantages over CT including: improved contrast resolution, functional imaging techniques, and the lack of ionizing radiation, which is of particular significance due to growing concerns over cumulative radiation exposure from multi-phase and repeat CT examinations. In particular, the non-ionizing property of MRI may be critical for patients who undergo repeated screening examinations for renal cell carcinoma including those patients under surveillance. By becoming the reference standard for renal mass imaging in clinical practice, multiparametric MRI may help defining the treatment strategy in a non-invasive fashion, resulting in a better selection of patients eligible for nephrectomy, other therapeutic options or surveillance based on tumor aggressiveness estimate, limiting the costs of care and improving patients' quality of life. The originality of this project lies in the opportunity to simultaneously assess the performances of mpMRI in diagnosing renal tumors in a routine clinical practice. In this context, the research will therefore contribute to the development of practical new technologies, strategies and tools for managing renal tumors. MpMRI will be performed in a time-efficient manner and to provide important information that is not available with standard renal MRI or CT-scan. Critical information provided through mpMRI will be used to adjust the therapeutic decision and more adequately select patients eligible for nephrectomy, other therapeutic options or surveillance. Another innovative aspect of the project is to bring together as teamwork several medical disciplines such as radiology, urology, oncology and pathology. The project has been developed and will be conducted within the framework of the French research network on kidney cancer UroCCR (www.uroccr.fr). INCa has been supporting this multidisciplinary network since 2011 and the web-based shared clinical and biological national database on kidney cancer UroCCR will be used.

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 (Actual)

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.
387

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 Locations

  • France
      • Angers, France, 49933
        • CHU Angers
      • Bordeaux, France, 33076
        • CHU Bordeaux
      • Créteil, France, 94010
        • APHP - Henri Mondor
      • Grenoble, France
        • CHU de Grenoble
      • Le Kremlin-Bicêtre, France, 94275
        • APHP - Hôpital Bicêtre
      • Lille, France, 59000
        • CHRU Lille
      • Lyon, France, 69444
        • CHU Lyon
      • Marseille, France, 13385
        • APHM - Hôpital de la Conception
      • Nancy, France, 54511
        • CHU Nancy
      • Nice, France, 06001
        • CHU Nice
      • Paris, France, 75020
        • APHP - Hôpital Tenon
      • Paris, France, 75743
        • APHP - Hôpital Necker
      • Paris, France
        • APHP - Hopital Bichat
      • Rennes, France, 35033
        • Chu Rennes
      • Rouen, France, 76031
        • CHU Rouen
      • Strasbourg, France, 67091
        • CHU Strasbourg
      • Toulouse, France, 31062
        • CHU Toulouse
      • Tours, France, 37044
        • CHU Tours

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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.
  • Patient's refusal of surgery, biopsy if necessary;
  • Minor
  • Person deprived of liberty
  • Person under trusteeship
  • Person under curatorship
  • Person under legal guardianship
  • Pregnant or nursing women.
  • Adults unable to express their consent
  • Females of child-bearing potential without a negative pregnancy test prior to MRI exam
  • Clinical follow-up not possible for psychological, family, social or geographic reasons.

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.
Other: Patients with small solid renal tumor
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)
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.

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 accuracy of multiparametric MR imaging (mpMRI)
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact of mpMRI on the clinical management of renal tumors
Time Frame: For MDC 1 up to 45 days after first urologist consultation, for MDC 2 up to 75 days after first urologist consultation
Comparison between management plan decided during MDC1 before mpMRI and during MDC2 after results from mpMRI.
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
Time Frame: At inclusion

Comparison between results on Likert scale obtained from 3 readings. Independent assessments by 2 radiologists from the investigating center blind from each other and 1 central reviewer.

Likert scale (0, 1, 2, 3 or 4) assessing the level of certainty of the malignant or benign nature of the tumor, as assessed by the radiologist on mpMRI images, after coding each of the detailed MRI parameters.
At inclusion
MR parameters in tumor subgroups based on histological findings
Time Frame: 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
MR parameters of each renal tumor subgroups assessed by pathology will be compare.
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
Time Frame: 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
Conclusions regarding aggressiveness of clear renal cell carcinoma assessed either by MR parameters or according to Fuhrman grade will be compare.
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
Time Frame: From inclusion up to 6 months
Occurrence assessment of adverse events following MRI, initial surgery, biopsy or ablation
From inclusion up to 6 months
Ancillary RADIOMICS project will be conducted to validate new applied mathematics tools allowing semi-automatic quantitative evaluation of MR images
Time Frame: For MRI results between from 1 day after urologist consultation up to 75 days. Algorithm results, probably 1 year after the end of the study
A First step will be to provide a precise definition of the tumor volume and will allow to define a signature of each tumor. A statistical learning algorithm will be run in order to propose for each patient a quantification of the probability of malignancy of the tumor according to demographic data and imaging parameters.
For MRI results between from 1 day after urologist consultation up to 75 days. Algorithm results, probably 1 year after the end of the study

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, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
November 27, 2018

Primary Completion (Actual)

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.
May 27, 2022

Study Completion (Actual)

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.
April 14, 2023

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).
February 26, 2018

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.
March 12, 2018

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.
March 19, 2018

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.
May 14, 2026

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.
May 11, 2026

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.
August 1, 2024

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.
  • CHUBX 2015/40

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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