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Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery

18. december 2017 opdateret af: 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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90033
        • Keck Hospital of USC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment (robot-assisted laparoscopic HIFU)
Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
Procedure: Robot-Assisted Laparoscopic Surgery
Undergo robot-assisted laparoscopic HIFU ablation
Procedure: High-Intensity Focused Ultrasound Ablation
Undergo robot-assisted laparoscopic HIFU ablation
Andre navne:
  • HIFU
Procedure: Therapeutic Laparoscopic Surgery
Undergo laparoscopic partial nephrectomy
Enhed: Sonatherm 600i Ultrasonic Lesion Generating System
Device used for high-intensity focused ultrasound ablation
Andre navne:
  • Sonatherm

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
Baseline (day of surgery)
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
Up to 4 years
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
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 4 years
Up to 4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Southern California

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Osamu Ukimura, University of Southern California

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

18. december 2017

Primær færdiggørelse (Forventet)

18. december 2018

Studieafslutning (Forventet)

18. december 2019

Datoer for studieregistrering

Først indsendt

17. februar 2015

Først indsendt, der opfyldte QC-kriterier

17. februar 2015

Først opslået (Skøn)

24. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4K-14-3 (Anden identifikator: USC Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH-bevilling/kontrakt)
  • NCI-2014-02636 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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