Status:
COMPLETED
Multiparametric MRI for Diagnosing Small Renal Tumors
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Renal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2023
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT03470285
Start Date
November 27 2018
End Date
April 14 2023
Last Update
August 2 2024
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Angers
Angers, France, 49933
2
CHU Bordeaux
Bordeaux, France, 33076
3
APHP - Henri Mondor
Créteil, France, 94010
4
CHU de Grenoble
Grenoble, France