Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery
18. desember 2017 oppdatert 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.
Studieoversikt
Status
Tilbaketrukket
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
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Los Angeles, California, Forente stater, 90033
- USC Norris Comprehensive Cancer Center
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Los Angeles, California, Forente stater, 90033
- Keck Hospital of USC
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
Undergo laparoscopic partial nephrectomy
Device used for high-intensity focused ultrasound ablation
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Planned ablation volume
Tidsramme: 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.
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Baseline (day of surgery)
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Necrosis volume
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tumor response
Tidsramme: Up to 4 years
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Up to 4 years
|
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Disease free interval
Tidsramme: From the date of treatment to the date of local or distant failure or until date of death, assessed up to 4 years
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From the date of treatment to the date of local or distant failure or until date of death, assessed up to 4 years
|
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Time to local failure
Tidsramme: From the date of treatment to the time to local failure, assessed up to 4 years
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From the date of treatment to the time to local failure, assessed up to 4 years
|
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Time to distant failure
Tidsramme: From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
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From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
|
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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
Tidsramme: Up to 4 years
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Up to 4 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Osamu Ukimura, University of Southern California
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
18. desember 2017
Primær fullføring (Forventet)
18. desember 2018
Studiet fullført (Forventet)
18. desember 2019
Datoer for studieregistrering
Først innsendt
17. februar 2015
Først innsendt som oppfylte QC-kriteriene
17. februar 2015
Først lagt ut (Anslag)
24. februar 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. desember 2017
Sist bekreftet
1. desember 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4K-14-3 (Annen identifikator: USC Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH-stipend/kontrakt)
- NCI-2014-02636 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
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