Renal CancerPhase 1NCT01012427
Percutaneous Renal Tumor Cryoablation Followed by Biopsy
A Phase 1 study testing percutaneous cryoablation in people with Renal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study is being done to test how effective cryoablation is in killing cancer cells. Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating freezing temperatures within a needle probe. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- percutaneous cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2015
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of at least one renal cancer smaller than or equal to 3.0 cm
- Adequate baseline imaging studies (CT/MRI) within 8 weeks of treatment or as clinically indicated.
- The following laboratory results should be within the following limits within the last 30 days prior to study day 1. Repeat blood work will be necessary if too much time has elapsed prior to the interventions.:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Serum bilirubin ≤ 2.0 mg/dL
Show all 16Show fewer
- Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Serum creatinine ≤ 2.0 mg/dL
- GFR >30 mL/min/m2
- International Normalized Ratio < 1.5 (INR)
- Partial Thromboplastin Time (PTT) <45 seconds
- Recovered from toxicity of any prior therapy
- Tumor accessible to probe placement without risk to adjacent critical structures.
- Tumor visible on non-contrast CT
- Patient willing and able to undergo imaging and percutaneous biopsy at 5-7 month intervals for 2 years and then at the discretion of the patient's physicians.
Who cannot join
- Intercurrent medical condition that renders the patient ineligible for cryoablation
- Women who are pregnant or breastfeeding.
- Tumor less than 5 mm to the renal pelvis, main renal vessel, ureter, or other vital structure
- Contraindication to MRI in patients in which it is required.
- Coagulopathy as defined above (Inclusion Criteria).
- Patients unwilling to return for follow-up biopsy and imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This study is being done to test how effective cryoablation is in killing cancer cells. Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating freezing temperatures within a needle probe. When this probe is inserted into a cancer, the freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators don't know how well cryoablation works at destroying the cancer. This study will allow us to check to see how well cryoablation works for kidney cancers. After the investigators destroy the kidney cancers using cryoablation, the investigators will followup with you every 5-7 months to make sure the cryoablation worked and that the cancer was destroyed.
- Conditions
- Renal Cancer
- Being tested
- percutaneous cryoablation
- Keywords
- Kidney, Cryoablation, 09-108
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous cryoablationProcedure or surgery
All patients will have percutaneous image guided core biopsies of the treatment site and CT or MR imaging at approximately 5-7 months following the cryoablation. They will have repeat imaging every 5-7 months for a period of two years, and if there is evidence of recurrence (ablation zone increase > 5 mm or increased enhancement 15 HU), then repeat biopsy will be obtained. Imaging follow-up past the two year point will be at the discretion of the patient's physicians.
| Study group | Role | What they receive |
|---|---|---|
| Patients with 3.0 cm or smaller renal cancer | Experimental | The interventions in this study are part of clinical care and include percutaneous image-guided biopsy, percutaneous renal tumor cryoablation, CT/MR imaging of the ablation bed, and repeat pathologic sampling of the tumor bed with percutaneous biopsy. The cryoablation is done as the therapeutic intervention in patients with small renal cancer. The CT/MR imaging is done to evaluate the treatment for residual disease after the ablation. The repeat biopsy (e.g. three cores) is done to confirm that the neoplasm has been eradicated. These patients have continued imaging, and if necessary, percutaneous biopsy to ensure no recurrent disease. Receives: Procedure: percutaneous cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy rate after percutaneous renal cryoablation.
Measured: 2 years
Secondary outcomes (4)
To determine the complication rate of percutaneous renal tumor cryoablation.
Measured: 2 years
To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.
Measured: 2 years
To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.
Measured: 2 years
To investigate predictors of efficacy after cryoablation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Solomon, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012427
- Sponsor's protocol ID
- 09-108
- Status last verified
- Jan 2016
- First submitted
- 11 Nov 2009
- Last updated
- 5 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Renal Tumor Cryoablation Followed by Biopsy
- ClinicalTrials.gov ID
- NCT01012427
- Acronym / sponsor ID
- 09-108
- Conditions
- Renal Cancer
- Keywords
- Kidney, Cryoablation, 09-108
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Nov 2009 (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.
This study is being done to test how effective cryoablation is in killing cancer cells. Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating freezing temperatures within a needle probe. When this probe is inserted into a cancer, the freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators don't know how well cryoablation works at destroying the cancer. This study will allow us to check to see how well cryoablation works for kidney cancers. After the investigators destroy the kidney cancers using cryoablation, the investigators will followup with you every 5-7 months to make sure the cryoablation worked and that the cancer was destroyed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with 3.0 cm or smaller renal cancer | Experimental | Procedure: percutaneous cryoablationThe interventions in this study are part of clinical care and include percutaneous image-guided biopsy, percutaneous renal tumor cryoablation, CT/MR imaging of the ablation bed, and repeat pathologic sampling of the tumor bed with percutaneous biopsy. The cryoablation is done as the therapeutic intervention in patients with small renal cancer. The CT/MR imaging is done to evaluate the treatment for residual disease after the ablation. The repeat biopsy (e.g. three cores) is done to confirm that the neoplasm has been eradicated. These patients have continued imaging, and if necessary, percutaneous biopsy to ensure no recurrent disease. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Presence of at least one renal cancer smaller than or equal to 3.0 cm
- Adequate baseline imaging studies (CT/MRI) within 8 weeks of treatment or as clinically indicated.
- The following laboratory results should be within the following limits within the last 30 days prior to study day 1. Repeat blood work will be necessary if too much time has elapsed prior to the interventions.:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
Key exclusion criteria (6 listed)
- Intercurrent medical condition that renders the patient ineligible for cryoablation
- Women who are pregnant or breastfeeding.
- Tumor less than 5 mm to the renal pelvis, main renal vessel, ureter, or other vital structure
- Contraindication to MRI in patients in which it is required.
- Coagulopathy as defined above (Inclusion Criteria).
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 |
|---|---|---|
| percutaneous cryoablationAll patients will have percutaneous image guided core biopsies of the treatment site and CT or MR imaging at approximately 5-7 months following the cryoablation. They will have repeat imaging every 5-7 months for a period of two years, and if there is evidence of recurrence (ablation zone increase > 5 mm or increased enhancement 15 HU), then repeat biopsy will be obtained. Imaging follow-up past the two year point will be at the discretion of the patient's physicians. | Procedure or surgery | Patients with 3.0 cm or smaller renal cancer |
Primary outcome
To determine the efficacy rate after percutaneous renal cryoablation.
Time frame: 2 years
4 secondary outcomes
To determine the complication rate of percutaneous renal tumor cryoablation.
Time frame: 2 years
To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.
Time frame: 2 years
To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.
Time frame: 2 years
To investigate predictors of efficacy after cryoablation.
Time frame: 2 years
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 5 Jan 2016.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
Related trials for Renal Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Stephen Solomon, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing percutaneous cryoablation in people with Renal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 16 inclusion and 6 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 5 Jan 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine the efficacy rate after percutaneous renal cryoablation. (time frame: 2 years). 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 5 Jan 2016.