Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Mas… (NCT02370342) | Clinical Trial Compass
WithdrawnNot Applicable
Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery
Stopped: No funding
United States0Started 2017-12-18
Plain-language summary
This clinical trial studies a type of ultrasound called robot-assisted laparoscopic high-intensity focused ultrasound for performing thermal ablative therapy, or sound wave therapy, in treating patients with small kidney masses undergoing partial removal of the kidney. The robot-assisted ultrasound probe takes images of the kidney to help doctors locate the mass. The probe then uses high frequency sound waves to target and ablate (or destroy) the kidney mass, which may be a cancerous tumor or benign tissue. Surgery is then performed to remove the part of the kidney with the mass. Robot-assisted laparoscopic high-intensity focused ultrasound for thermal ablative therapy may be safer and help doctors see the tumor better when performing kidney surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of an enhancing solid renal mass =\< 3.0 cm on radiological examination
* Tumors with a depth of not greater than 3.0 cm from a laparoscopically accessible surface-meaning no part of the tumor should be deeper than 3.0 cm from the surface
* Patients with solitary kidneys, bilateral renal tumors, compromised renal function (baseline creatinine \> 1.4)
* Subjects must have given written informed consent
* Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected, but the subject should have recovered from the effects of these or of any prior surgery
* Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
* Absolute neutrophil count (ANC) \>= 1500 mm\^-3
* Platelet count \>= 100,000 mm\^-3
* Hemoglobin \>= 10 g/dl
* Prothrombin time (PT) =\< 1.5 times upper limit of laboratory normal (ULN)
* Activated partial thromboplastin time =\< 1.5 times ULN
* Urea and serum creatinine \< 2.5 times ULN
* Total bilirubin \< 1.5 times ULN
* Aspartate aminotransferase (AST) =\< 3 times ULN
* Alkaline phosphatase \< 2 times ULN, unless arising from bone
Exclusion Criteria:
* \< 90% solid component on screening cross-sectional imaging
* Subjects deemed unsuitable candidates and not medically optimized for partial nephrectomy
* Tumors greater than 3.0 cm at their widest point
* Subjects with tumors lying \< 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.