Status:
COMPLETED
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses
Lead Sponsor:
Indiana University
Collaborating Sponsors:
SonaCare Medical
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity focused ultrasound to target and ablate tumors. It also does not require piercing the tumor with a needle a...
Detailed Description
This study uses a treat and resect model where ablation is followed by a partial nephrectomy. This will allow for the ablation to be evaluated for necrosis and targeting accuracy. It will also ensure ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- ≥ 18 years of age.
- Must provide written informed consent
- Must have presence of an enhancing solid renal mass ≤ 3.0 cm on CT or MRI
- Must be scheduled for laparoscopic robot assisted partial nephrectomy of renal mass.
- Must have an expected survival status of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- Previous chemotherapy, and/or biological therapy for cancer are permitted. The subject should have recovered from the effects of these or of any prior surgery.
- Women of child bearing potential must have negative pregnancy test (urine or serum) prior to study enrollment. Females must agree to adequate birth control if conception is possible during the study.
- All toxicities from prior therapy must be recovered to a grade 1 or better according to the Clavien-Dindo Classification system.
- If previous biopsy of mass has been done, pathology must be consistent with renal cell carcinoma (RCC).
- Exclusion Criteria
- \< 90% solid component of the tumor on screening cross-sectional imaging (CT/MRI)
- Prior ablative or surgical treatment of the lesion
- Masses located close to the hilar vessels or at locations that cannot be accessed with the HIFU probe
- The patient has only one kidney
- Multiple or bilateral renal masses
- Failure to meet the following laboratory levels on preoperative screening:
- Platelet count ≥ 100,000 mm3
- Hemoglobin ≥ 10 g/dl.
- Prothrombin Time (PT) ≤ 1.5 times upper limit of laboratory normal (ULN).
- Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN.
- Serum creatinine \< 2.5 times ULN.
- Hepatic toxicity grade 2 (using CTCAE version 4 standard definitions)
- Inability to hold anticoagulation for surgery due to high risk of a cerebral vascular event, myocardial event, or like risk (ASA may be continued)
- Abdominal obesity that would, in the assessment of the PI, make the HIFU ablation difficult
- Participation in another investigational trial concurrently or within 30 days prior to enrollment
- Subjects with a diagnosis of metastatic disease who are currently receiving treatment or who are not in remission
- Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study
- \-
Exclusion
Key Trial Info
Start Date :
September 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02248389
Start Date
September 4 2014
End Date
June 8 2015
Last Update
March 25 2019
Active Locations (1)
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1
IU Health University Hospital
Indianapolis, Indiana, United States, 46202