Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy

Not Applicable

Completed

• Conditions: Renal Tumors Less Than 4 cm
• Interventions: Device: Galil Medical patented 17G Cryoablation Needles

• Registration Number: NCT01471002
• Lead Sponsor: University Hospital, Strasbourg, France

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Primary Completion: 2015-12
• Status Verified: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-07
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal cancer without nephrectomy	Galil Medical patented 17G Cryoablation Needles	patients with renal cancer that cannot be offered a partial nephrectomy

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Nouvel Hôpital Civil; 🇫🇷 Strasbourg, Alsace, France