Kidney CancerNCT01894607
Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
A study testing Contrast Enhanced Intraoperative Ultrasound, DEFINITY and Phone Call in people with Kidney Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research is to learn how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Contrast Enhanced Intraoperative Ultrasound, DEFINITY and Phone Call
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy.
- Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy.
- Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages)
Who cannot join
- Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy.
- Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere)
- Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts.
- Pediatric patients less than 18 years of age.
- Pregnant or nursing mothers.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Feasibility Study of Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
The goal of this clinical research is to learn how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys.
Read the detailed description
DEFINITY is a contrast agent that is used to create better quality ultrasound images.
On the day before or the day of the standard of care surgery, women who are able to become pregnant must have a negative blood or urine pregnancy test. If it a blood pregnancy test is performed, a portion of blood will be used from routine blood draws that are collected as part of your standard of care surgery.
During your standard of care surgery, the radiologist will take images and videos with an ultrasound machine before you are given the contrast agent. This is done to learn if cancer has spread around the kidney.
You will then receive the DEFINITY by vein over about 1 minute. After you receive the injection of DEFINITY, the radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Length of Study:
Your active participation in this study will be over after you have completed the follow-up visit.
Follow-Up Phone Call:
You will have a follow-up phone call 30 days after your standard of care surgery is complete to review any side effects you may be having. This call should take about 10 minutes to complete.
This is an investigational study. DEFINITY is FDA approved and commercially available for use in contrast enhanced echocardiography. It is not FDA approved or commercially available for use in radiology.
Up to 11 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Kidney Cancer
- Being tested
- Contrast Enhanced Intraoperative Ultrasound, DEFINITY, Phone Call
- Keywords
- Kidney Cancer, Renal Mass, Open partial nephrectomy, Ultrasound-guided surgery, DEFINITY, Contrast agent, Phone call
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Intraoperative UltrasoundProcedure or surgery
During standard of care surgery, radiologist will take images and videos with an ultrasound machine before and after patient given the contrast agent.
DEFINITYDrug
During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.
Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Phone CallBehavioural
Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.
| Study group | Role | What they receive |
|---|---|---|
| Contrast Enhanced Intraoperative Ultrasound | Experimental | During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.
Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having. Receives: Procedure: Contrast Enhanced Intraoperative Ultrasound; Drug: DEFINITY; Behavioral: Phone Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Capture of IO-CEUS Images
Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.
Measured: 1 day
Secondary outcomes (1)
Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)
Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ott Le, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894607
- Sponsor's protocol ID
- 2012-0124
- Other IDs
- NCI-2013-02232
- Status last verified
- Mar 2016
- First submitted
- 3 Jul 2013
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT01894607
- Acronym / sponsor ID
- 2012-0124
- Conditions
- Kidney Cancer
- Keywords
- Kidney Cancer, Renal Mass, Open partial nephrectomy, Ultrasound-guided surgery, DEFINITY, Contrast agent, Phone call
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 15 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research is to learn how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys.
Detailed description
DEFINITY is a contrast agent that is used to create better quality ultrasound images.
On the day before or the day of the standard of care surgery, women who are able to become pregnant must have a negative blood or urine pregnancy test. If it a blood pregnancy test is performed, a portion of blood will be used from routine blood draws that are collected as part of your standard of care surgery.
During your standard of care surgery, the radiologist will take images and videos with an ultrasound machine before you are given the contrast agent. This is done to learn if cancer has spread around the kidney.
You will then receive the DEFINITY by vein over about 1 minute. After you receive the injection of DEFINITY, the radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Length of Study:
Your active participation in this study will be over after you have completed the follow-up visit.
Follow-Up Phone Call:
You will have a follow-up phone call 30 days after your standard of care surgery is complete to review any side effects you may be having. This call should take about 10 minutes to complete.
This is an investigational study. DEFINITY is FDA approved and commercially available for use in contrast enhanced echocardiography. It is not FDA approved or commercially available for use in radiology.
Up to 11 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast Enhanced Intraoperative Ultrasound | Experimental | Procedure: Contrast Enhanced Intraoperative Ultrasound, Drug: DEFINITY, Behavioral: Phone CallDuring standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent. Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier. Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy.
- Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy.
- Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages)
Key exclusion criteria (5 listed)
- Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy.
- Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere)
- Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts.
- Pediatric patients less than 18 years of age.
- Pregnant or nursing mothers.
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 |
|---|---|---|
| Contrast Enhanced Intraoperative UltrasoundDuring standard of care surgery, radiologist will take images and videos with an ultrasound machine before and after patient given the contrast agent. | Procedure or surgery | Contrast Enhanced Intraoperative Ultrasound |
| DEFINITYDuring standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent. Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier. | Drug | Contrast Enhanced Intraoperative Ultrasound |
| Phone CallFollow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having. | Behavioural | Contrast Enhanced Intraoperative Ultrasound |
Primary outcome
Successful Capture of IO-CEUS Images
Time frame: 1 day
Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.
1 secondary outcome
Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ott Le, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Enhanced Intraoperative Ultrasound, DEFINITY and Phone Call in people with Kidney Cancer, run by M.D. Anderson Cancer Center 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 3 inclusion and 5 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 14 Apr 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Capture of IO-CEUS Images (time frame: 1 day). 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 14 Apr 2016.