Renal Tumors Less Than 4 cmCRYOREINNCT01471002
Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
A study testing Galil Medical patented 17G Cryoablation Needles in people with Renal Tumors Less Than 4 cm, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Tumors Less Than 4 cm
- What is being tested?
- Galil Medical patented 17G Cryoablation Needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- - 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
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).
- Conditions
- Renal Tumors Less Than 4 cm
- Being tested
- Galil Medical patented 17G Cryoablation Needles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galil Medical patented 17G Cryoablation NeedlesDevice
| Study group | Role | What they receive |
|---|---|---|
| Renal cancer without nephrectomy | Experimental | patients with renal cancer that cannot be offered a partial nephrectomy Receives: Device: Galil Medical patented 17G Cryoablation Needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Tumors Less Than 4 cmStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afshin GANGI, PU-PH, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471002
- Sponsor's protocol ID
- 5062
- Acronym
- CRYOREIN
- Status last verified
- Apr 2016
- First submitted
- 3 Nov 2011
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT01471002
- Acronym / sponsor ID
- CRYOREIN / 5062
- Conditions
- Renal Tumors Less Than 4 cm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal cancer without nephrectomy | Experimental | Device: Galil Medical patented 17G Cryoablation Needlespatients with renal cancer that cannot be offered a partial nephrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- About 75 years, or
- Whatever the age:
- 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.
Key exclusion criteria (14 listed)
- - 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galil Medical patented 17G Cryoablation Needles | Device | Renal cancer without nephrectomy |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afshin GANGI, PU-PH principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galil Medical patented 17G Cryoablation Needles in people with Renal Tumors Less Than 4 cm, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.