Carcinoma, Renal CellPhase 1HIFU-KIDNEYNCT02248389
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses
A Phase 1 study testing Sonatherm 600i ablation system in people with Carcinoma, Renal Cell, run by Indiana University at 1 site in United States.
Trial summary
The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity focused ultrasound to target and ablate tumors. It also does not require piercing the tumor with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Sonatherm 600i ablation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2014to 8 Jun 2015
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age.
- Must provide written informed consent
- Must have presence of an enhancing solid renal mass ≤ 3.0 cm on CT or MRI
- Must be scheduled for laparoscopic robot assisted partial nephrectomy of renal mass.
- Must have an expected survival status of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Show all 10Show fewer
- Previous chemotherapy, and/or biological therapy for cancer are permitted. The subject should have recovered from the effects of these or of any prior surgery.
- Women of child bearing potential must have negative pregnancy test (urine or serum) prior to study enrollment. Females must agree to adequate birth control if conception is possible during the study.
- All toxicities from prior therapy must be recovered to a grade 1 or better according to the Clavien-Dindo Classification system.
- If previous biopsy of mass has been done, pathology must be consistent with renal cell carcinoma (RCC).
Who cannot join
- < 90% solid component of the tumor on screening cross-sectional imaging (CT/MRI)
- Prior ablative or surgical treatment of the lesion
- Masses located close to the hilar vessels or at locations that cannot be accessed with the HIFU probe
- The patient has only one kidney
- Multiple or bilateral renal masses
- Failure to meet the following laboratory levels on preoperative screening:
Show all 18Show fewer
- Platelet count ≥ 100,000 mm3
- Hemoglobin ≥ 10 g/dl.
- Prothrombin Time (PT) ≤ 1.5 times upper limit of laboratory normal (ULN).
- Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN.
- Serum creatinine < 2.5 times ULN.
- Hepatic toxicity grade 2 (using CTCAE version 4 standard definitions)
- Inability to hold anticoagulation for surgery due to high risk of a cerebral vascular event, myocardial event, or like risk (ASA may be continued)
- Abdominal obesity that would, in the assessment of the PI, make the HIFU ablation difficult
- Participation in another investigational trial concurrently or within 30 days prior to enrollment
- Subjects with a diagnosis of metastatic disease who are currently receiving treatment or who are not in remission
- Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity focused ultrasound to target and ablate tumors. It also does not require piercing the tumor with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus, there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback could replace RF and Cryo for the treatment of small renal masses where the invasiveness of full resection partial nephrectomy is contraindicated due to patient comorbidities.
Read the detailed description
This study uses a treat and resect model where ablation is followed by a partial nephrectomy. This will allow for the ablation to be evaluated for necrosis and targeting accuracy. It will also ensure cancer safety prior validation of the HIFU device. The applied heat of HIFU ablation could improve hemostasis and blood loss.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sonatherm 600i ablation system
- Keywords
- carcinoma, renal cell, ablation, laparoscopic surgery, high intensity focused ultrasound
- 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.
Sonatherm 600i ablation systemDevice
HIFU ablation of tumor.
| Study group | Role | What they receive |
|---|---|---|
| Ablation arm | Experimental | Each person in study will receive ablation of their renal tumor followed by standard partial nephrectomy. Receives: Device: Sonatherm 600i ablation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative and postoperative complications
Observing complications as defined by the Clavien system (1-5).
Measured: 4-months
Secondary outcomes (3)
Necrosis
A microscopic analysis will be performed to assess necrosis within the ablation zone.
Measured: 1-week
Tumor targeting
The ablation border beyond the tumor will be measured on pathologic analysis with success being defined as 1-10mm.
Measured: 1-week
Surgeon rated ease of use
A questionnaire assessing the ease of use of the Sonatherm instrument will be given to the surgeon after each case.
Measured: 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start4 Sep 2014
- Primary completion8 Jun 2015
- Study completion8 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- SonaCare Medical
- Responsible party
- Principal investigator, Chandru Sundaram, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248389
- Sponsor's protocol ID
- IUCRO-0474
- Acronym
- HIFU-KIDNEY
- Status last verified
- Mar 2019
- First submitted
- 19 Sep 2014
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses
- ClinicalTrials.gov ID
- NCT02248389
- Acronym / sponsor ID
- HIFU-KIDNEY / IUCRO-0474
- Conditions
- Carcinoma, Renal Cell
- Keywords
- carcinoma, renal cell, ablation, laparoscopic surgery, high intensity focused ultrasound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- SonaCare Medical
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- 8 Jun 2015 (actual)
- Study completion
- 8 Jun 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity focused ultrasound to target and ablate tumors. It also does not require piercing the tumor with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus, there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback could replace RF and Cryo for the treatment of small renal masses where the invasiveness of full resection partial nephrectomy is contraindicated due to patient comorbidities.
Detailed description
This study uses a treat and resect model where ablation is followed by a partial nephrectomy. This will allow for the ablation to be evaluated for necrosis and targeting accuracy. It will also ensure cancer safety prior validation of the HIFU device. The applied heat of HIFU ablation could improve hemostasis and blood loss.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation arm | Experimental | Device: Sonatherm 600i ablation systemEach person in study will receive ablation of their renal tumor followed by standard partial nephrectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 years of age.
- Must provide written informed consent
- Must have presence of an enhancing solid renal mass ≤ 3.0 cm on CT or MRI
- Must be scheduled for laparoscopic robot assisted partial nephrectomy of renal mass.
- Must have an expected survival status of at least 3 months.
Key exclusion criteria (18 listed)
- < 90% solid component of the tumor on screening cross-sectional imaging (CT/MRI)
- Prior ablative or surgical treatment of the lesion
- Masses located close to the hilar vessels or at locations that cannot be accessed with the HIFU probe
- The patient has only one kidney
- Multiple or bilateral renal masses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonatherm 600i ablation systemHIFU ablation of tumor. | Device | Ablation arm |
Primary outcome
Operative and postoperative complications
Time frame: 4-months
Observing complications as defined by the Clavien system (1-5).
3 secondary outcomes
Necrosis
Time frame: 1-week
Tumor targeting
Time frame: 1-week
Surgeon rated ease of use
Time frame: 1-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
Related trials for Carcinoma, Renal Cell
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sonatherm 600i ablation system in people with Carcinoma, Renal Cell, run by Indiana University at 1 site 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 10 inclusion and 18 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: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Operative and postoperative complications (time frame: 4-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2019.