Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT01471002
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01471002
Study Brief:
Protocol Section:
NCT01471002