Renal Tumors Less Than 4 cm
Conditions
Brief summary
The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a partial nephrectomy. The oncologic outcome will be assessed by the presence or absence of residue or recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6, M12).
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Patients should have the following characteristics: * About 75 years, or * Whatever the age: * A context of family-type tumor (VHL, hereditary carcinoma, tubulo-papillary ...); * or solitary kidney, when the tumor is not easily accessible for nephron-sparing surgery: Malignant centro-hilar or intra-parenchymal; * or in a local recurrence (single or multiple) after partial nephrectomy (within a limit of 3 tumors to be treated); * or in a subject with impaired renal function and therefore at risk of severe renal insufficiency (risk defined by a creatinine clearance below 30 ml / min by MDRD formula); * and who do not present any contra-indication for cryoablation treatment. The tumor(s) should meet the following criteria: * Presence of one to three solid tumors of the native renal parenchyma with a largest diameter less than (or equal to) 40 mm, which corresponds to a maximum volume of about 32 cc, as measured by MRI. * A preoperative MRI is essential since this technique presents a higher sensitivity. This control will also give more consistency to the evaluation of the radiological semiology at follow-up. * And its/their location(s) will be accessible to a percutaneous approach. The search of metastases, including a thoracic CT scan, should be negative. Exclusion Criter ia: * \- Partial nephrectomy feasible in good technical and oncologic conditions in patients under 75 years and in the absence of family tumors. * Contraindication to any form of sedation. * Irreversible coagulopathy * Tumor\> 4cm * Contraindication to MRI or gadolinium (proven allergy). NB: Patients with a glomerular filtration rate below 30 ml/min/1, 73 m2 will be injected with a single dose of the macrocyclic gadolinium with the highest thermodynamic stability (Dotarem or Prohance), given the united recommendations of AFSSAPS and EMA (European Medicines Agency) \[45\]. On the contrary, the linear molecules of gadolinium, due to their lower stability, will be contra-indicated because of the risk of systemic nephrogenic fibrosis (FNS). * Recurrence on the same location after a procedure performed out of the thermoablation protocol. * Biopsy proven benign tumor * Predominantly cystic tumor, defined by a necrotic content constituting over one third of tumor volume * Presence of endo-venous extension, of proven secondary extensions, visceral or in the lymph nodes (especially lung). In this regard, a thoracic CT scan will be routinely required before treatment, according to the recommendations of urological societies. * Psychiatric disorders and adults under guardianship * Pregnancy or breastfeeding * Minor patients * Legal safeguard * Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI | 1 year | The success of cryoablation will be declared if the control at 1 year shows no suspicious contrast enhancement (the suspicious character is defined by significant contrast uptake (\>15%) and heterogeneous or nodular or crescent-shape contrast enhancement) and if the cryolesion is not progressing in size compared to early post-ablation control (M1). |
Countries
France