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Renal CarcinomaNCT02370342

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

A study testing Robot-Assisted Laparoscopic Surgery, High-Intensity Focused Ultrasound Ablation and Therapeutic Laparoscopic Surgery in people with Renal Carcinoma and Renal Mass, run by University of Southern California at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Carcinoma, Renal Mass
What is being tested?
Robot-Assisted Laparoscopic Surgery, High-Intensity Focused Ultrasound Ablation and Therapeutic Laparoscopic Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
18 Dec 2017to 18 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • < 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Robot-Assisted Laparoscopic Surgery, High-Intensity Focused Ultrasound Ablation, Therapeutic Laparoscopic Surgery, Sonatherm 600i Ultrasonic Lesion Generating System
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-Assisted Laparoscopic SurgeryProcedure or surgery

    Undergo robot-assisted laparoscopic HIFU ablation

  • High-Intensity Focused Ultrasound AblationProcedure or surgery

    Also called HIFU

    Undergo robot-assisted laparoscopic HIFU ablation

  • Therapeutic Laparoscopic SurgeryProcedure or surgery

    Undergo laparoscopic partial nephrectomy

  • Sonatherm 600i Ultrasonic Lesion Generating SystemDevice

    Also called Sonatherm

    Device used for high-intensity focused ultrasound ablation

Study groups in NCT02370342
Study groupRoleWhat they receive
Treatment (robot-assisted laparoscopic HIFU)ExperimentalPatients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
Receives: Procedure: Robot-Assisted Laparoscopic Surgery; Procedure: High-Intensity Focused Ultrasound Ablation; Procedure: Therapeutic Laparoscopic Surgery; Device: Sonatherm 600i Ultrasonic Lesion Generating System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Planned ablation volume

    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.

    Measured: Baseline (day of surgery)

  2. Necrosis volume

    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.

    Measured: Baseline (day of surgery)

Secondary outcomes (5)

  1. Tumor response

    Measured: Up to 4 years

  2. Disease free interval

    Measured: From the date of treatment to the date of local or distant failure or until date of death, assessed up to 4 years

  3. Time to local failure

    Measured: From the date of treatment to the time to local failure, assessed up to 4 years

  4. Time to distant failure

    Measured: From the date of treatment to the time to documented metastatic disease, assessed up to 4 years

  5. 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

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2015 (estimated)
  2. Study start18 Dec 2017 (estimated)
  3. Primary completion18 Dec 2018 (estimated)
  4. Study completion18 Dec 2019 (estimated)

Why it stopped: No funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02370342
Sponsor's protocol ID
4K-14-3
Other IDs
NCI-2014-02636, 4K-14-3, P30CA014089
Status last verified
Dec 2017
First submitted
17 Feb 2015
Last updated
20 Dec 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Robot-Assisted Laparoscopic Surgery, High-Intensity Focused Ultrasound Ablation and Therapeutic Laparoscopic Surgery in people with Renal Carcinoma and Renal Mass, run by University of Southern California at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Planned ablation volume (time frame: Baseline (day of surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02370342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.

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