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New MRI method could spare thousands from unnecessary kidney surgery

NCT ID NCT03470285

Diagnosis Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This completed study tested whether a special type of MRI (multiparametric MRI) can accurately tell the difference between benign and malignant small kidney tumors. About 387 adults with small solid kidney masses (1.5-4 cm) were scanned before surgery or biopsy. The goal was to see if the MRI could reliably identify benign tumors, potentially allowing some patients to avoid unnecessary surgery. The study involved 18 centers and multiple radiologists to check consistency.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multiparametric MR imaging (mpMRI)
What this could lead to
If successful, mpMRI could help doctors decide which small kidney tumors need surgery and which can be safely monitored, reducing unnecessary operations.
What could go wrong
This is a completed diagnostic accuracy study, not a treatment trial. The MRI technique may not be accurate enough in all cases, and results depend on radiologist interpretation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

387 people

The number who actually took part.

Started

Nov 2018

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

kidney cancer renal carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cancer

Contacts and locations

Locations

  • APHM - Hôpital de la Conception

    Marseille, 13385, France

  • APHP - Henri Mondor

    Créteil, 94010, France

  • APHP - Hôpital Bichat

    Paris, France

  • APHP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • APHP - Hôpital Necker

    Paris, 75743, France

  • APHP - Hôpital Tenon

    Paris, 75020, France

  • CHRU Lille

    Lille, 59000, France

  • CHU Angers

    Angers, 49933, France

  • CHU Bordeaux

    Bordeaux, 33076, France

  • CHU Lyon

    Lyon, 69444, France

  • CHU Nancy

    Nancy, 54511, France

  • CHU Nice

    Nice, 06001, France

  • CHU Rennes

    Rennes, 35033, France

  • CHU Rouen

    Rouen, 76031, France

  • CHU Strasbourg

    Strasbourg, 67091, France

  • CHU Toulouse

    Toulouse, 31062, France

  • CHU Tours

    Tours, 37044, France

  • CHU de Grenoble

    Grenoble, France

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