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

Primary Purpose

Renal Tumors Less Than 4 cm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Galil Medical patented 17G Cryoablation Needles
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Tumors Less Than 4 cm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nouvel Hôpital Civil

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal cancer without nephrectomy

Arm Description

patients with renal cancer that cannot be offered a partial nephrectomy

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 3, 2011
Last Updated
April 7, 2016
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01471002
Brief Title
Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
Acronym
CRYOREIN
Official Title
Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Tumors Less Than 4 cm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal cancer without nephrectomy
Arm Type
Experimental
Arm Description
patients with renal cancer that cannot be offered a partial nephrectomy
Intervention Type
Device
Intervention Name(s)
Galil Medical patented 17G Cryoablation Needles
Primary Outcome Measure Information:
Title
Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI
Description
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).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin GANGI, PU-PH
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nouvel Hôpital Civil
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

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

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