Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
Conditions
Renal Tumors Less Than 4 cm
Conditions: official terms
Kidney Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Galil Medical patented 17G Cryoablation Needles
Type: Device
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Nouvel Hôpital Civil
Strasbourg, Alsace, France
Status: Recruiting
Contact: Afshin GANGI, PU-PH - 03 69 55 07 56 - gangi@unistra.fr
Start Date
November 2011
Completion Date
May 2014
Sponsors
University Hospital, Strasbourg, France
Source
University Hospital, Strasbourg, France
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page