Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery
18 december 2017 uppdaterad av: University of Southern California
Robot-Assisted Laparoscopic HIFU (High-Intensity Focused Ultrasound) for Thermal Ablative Therapy of Small Renal Mass: Corroborating With Robot-Assisted Laparoscopic Partial Nephrectomy Specimens
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.
Studieöversikt
Status
Indragen
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of laparoscopic high-intensity focused ultrasound (HIFU) for the treatment of localized primary renal cancer to evaluate histological accuracy in successful ablation of the small renal mass, matched with intraoperative targeting.
SECONDARY OBJECTIVES:
I. To evaluate the safety and toxicity of laparoscopic HIFU for patients with primary renal cancer.
II. To evaluate the technical success of laparoscopic HIFU ablation.
OUTLINE:
Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
After completion of study treatment, patients are followed up at 2 days, 2 weeks, 1 month, 6 months, 12 months, and then annually for up to 3 years.
Studietyp
Interventionell
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90033
- USC Norris Comprehensive Cancer Center
-
Los Angeles, California, Förenta staterna, 90033
- Keck Hospital of USC
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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 cm from sensitive structures such as the ureter, renal vessels or adjacent bowel
- Subjects on concurrent anticoagulant, or immunosuppressive medication
- Subjects on anti-cancer medication whether biologic or pharmaceutical
- Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to HIFU treatment)
- Subjects assessed by consultant anesthetist as unsuitable for general anesthetic
- Subjects having had prior ablation therapy on the same tumor
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment (robot-assisted laparoscopic HIFU)
Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
|
Undergo robot-assisted laparoscopic HIFU ablation
Undergo robot-assisted laparoscopic HIFU ablation
Andra namn:
Undergo laparoscopic partial nephrectomy
Device used for high-intensity focused ultrasound ablation
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Planned ablation volume
Tidsram: Baseline (day of surgery)
|
Ablation area of the kidney mass will be compared to the planned area under histopathologic review.
Analyzed using a one-sided one sample T-test.
|
Baseline (day of surgery)
|
|
Necrosis volume
Tidsram: Baseline (day of surgery)
|
Ablation area of the kidney mass will be compared to the planned area under histopathologic review.
Analyzed using a one-sided one sample T-test.
|
Baseline (day of surgery)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Tumor response
Tidsram: Up to 4 years
|
Up to 4 years
|
|
Disease free interval
Tidsram: From the date of treatment to the date of local or distant failure or until date of death, assessed up to 4 years
|
From the date of treatment to the date of local or distant failure or until date of death, assessed up to 4 years
|
|
Time to local failure
Tidsram: From the date of treatment to the time to local failure, assessed up to 4 years
|
From the date of treatment to the time to local failure, assessed up to 4 years
|
|
Time to distant failure
Tidsram: From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
|
From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
|
|
Overall success rate, measured as the combination of achieving local control of kidney cancer and demonstration of a favorable safety profile evidenced by enumeration of all adverse events by type, severity, and frequency
Tidsram: Up to 4 years
|
Up to 4 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Osamu Ukimura, University of Southern California
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
18 december 2017
Primärt slutförande (Förväntat)
18 december 2018
Avslutad studie (Förväntat)
18 december 2019
Studieregistreringsdatum
Först inskickad
17 februari 2015
Först inskickad som uppfyllde QC-kriterierna
17 februari 2015
Första postat (Uppskatta)
24 februari 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 december 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 december 2017
Senast verifierad
1 december 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4K-14-3 (Annan identifierare: USC Norris Comprehensive Cancer Center)
- P30CA014089 (U.S.S. NIH-anslag/kontrakt)
- NCI-2014-02636 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
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