Renal Tumors Less Than 4 cm Clinical Trial
— CRYOREINOfficial title:
Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
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).
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | April 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Nouvel Hôpital Civil | Strasbourg | Alsace |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI | 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). | 1 year | No |