Clinical trial · Interventional
Multiparametric MRI for Diagnosing Small Renal Tumors
Diagnostic Value of Multiparametric MR Imaging of Small Solid Renal Tumors (IRMK01)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cancer | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiparametric MR imaging (mpMRI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients with small solid renal tumor
- description
- In addition to the actual workflow for a patient presenting a renal tumor, patients will undergo an additional Multiparametric MR imaging (mpMRI).
- interventionNames
- Procedure: Multiparametric MR imaging (mpMRI)
Primary outcomes (1)
- measure
- Diagnostic accuracy of multiparametric MR imaging (mpMRI)
- timeFrame
- 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
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTGalmiche 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
- RESULTCornelis 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