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

Overview

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).

Full Title of Study: “Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Interventions

  • Device: Galil Medical patented 17G Cryoablation Needles

Arms, Groups and Cohorts

  • Experimental: Renal cancer without nephrectomy
    • patients with renal cancer that cannot be offered a partial nephrectomy

Clinical Trial Outcome Measures

Primary Measures

  • Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Afshin GANGI, PU-PH, Principal Investigator, Hôpitaux universitaires de Strasbourg

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