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Renal CancerIRMK01NCT03470285

Multiparametric MRI for Diagnosing Small Renal Tumors

A study testing Multiparametric MR imaging (mpMRI) in people with Renal Cancer, run by University Hospital, Bordeaux at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cancer
What is being tested?
Multiparametric MR imaging (mpMRI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
387 participants
Where
18 sitesFrance
Study dates
27 Nov 2018to 14 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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;
Show all 10Show fewer
  • 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

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites
  • CHU Angers

    Angers, 49933

  • CHU Bordeaux

    Bordeaux, 33076

  • APHP - Henri Mondor

    Créteil, 94010

  • CHU de Grenoble

    Grenoble

  • APHP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • CHRU Lille

    Lille, 59000

  • CHU Lyon

    Lyon, 69444

  • APHM - Hôpital de la Conception

    Marseille, 13385

  • CHU Nancy

    Nancy, 54511

  • CHU Nice

    Nice, 06001

  • APHP - Hôpital Tenon

    Paris, 75020

  • APHP - Hôpital Necker

    Paris, 75743

  • APHP - Hôpital Bichat

    Paris

  • CHU Rennes

    Rennes, 35033

  • CHU Rouen

    Rouen, 76031

  • CHU Strasbourg

    Strasbourg, 67091

  • CHU Toulouse

    Toulouse, 31062

  • CHU Tours

    Tours, 37044

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Renal Cancer
Being tested
Multiparametric MR imaging (mpMRI)
Keywords
Mulitparametric MR Imaging, Small solid renal tumors
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiparametric MR imaging (mpMRI)Procedure or surgery

    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.

Study groups in NCT03470285
Study groupRoleWhat they receive
Patients with small solid renal tumorOtherIn addition to the actual workflow for a patient presenting a renal tumor, patients will undergo an additional Multiparametric MR imaging (mpMRI).
Receives: Procedure: Multiparametric MR imaging (mpMRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Impact of mpMRI on the clinical management of renal tumors

    Comparison between management plan decided during MDC1 before mpMRI and during MDC2 after results from mpMRI.

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

  2. Inter-observer reproducibility of mpMRI

    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.

    Measured: At inclusion

  3. MR parameters in tumor subgroups based on histological findings

    MR parameters of each renal tumor subgroups assessed by pathology will be compare.

    Measured: 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

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

    Conclusions regarding aggressiveness of clear renal cell carcinoma assessed either by MR parameters or according to Fuhrman grade will be compare.

    Measured: 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

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

    Occurrence assessment of adverse events following MRI, initial surgery, biopsy or ablation

    Measured: From inclusion up to 6 months

  6. Ancillary RADIOMICS project will be conducted to validate new applied mathematics tools allowing semi-automatic quantitative evaluation of MR images

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2018
  2. Study start27 Nov 2018
  3. Primary completion27 May 2022
  4. Study completion14 Apr 2023

Resources

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
387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03470285
Sponsor's protocol ID
CHUBX 2015/40
Other IDs
2016-A01899-42
Acronym
IRMK01
Status last verified
Aug 2024
First submitted
26 Feb 2018
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27959744
  • 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.

    PubMed 28237280

Questions about this trial

What is this clinical trial studying?

A study testing Multiparametric MR imaging (mpMRI) in people with Renal Cancer, run by University Hospital, Bordeaux at 18 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 10 inclusion and 25 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: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03470285, which also lists 2 linked publications.

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 3 Aug 2026.

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