Chronic Kidney DiseasePhase 2CEUS-CKDNCT02684435
Contrast-enhanced Ultrasound of the Kidney
A Phase 2 study testing Perflutren lipid microsphere in people with Chronic Kidney Disease and Cystic Kidney Disease, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Cystic Kidney Disease
- What is being tested?
- Perflutren lipid microsphere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to 9 Jul 2018
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for the present study, patients must meet the following criteria:
- Able to provide written informed consent
- Willing to comply with protocol requirements
- At least 18 years of age
- Have kidney disease, defined as either CKD II-VI, determined by estimated glomerular filtration rate (GFR) of <90 and derived from serum creatinine measurements, or albuminuria/proteinuria, determined by albumin to creatinine ratio or protein to creatinine ratio of >30mg/gm, or having received a kidney transplant
- Have at least one kidney lesion identified but incompletely characterized on a non-contrasted US, CT, or MR exam for which the patient's provider recommends follow-up studies or further evaluation with an additional imaging tests.
Who cannot join
- Patients who meet any of the following criteria will be excluded for enrollment:
- Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)
- Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
- Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome
- Active cardiac disease including any of the following:
- Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
Show all 19Show fewer
- Unstable angina.
- Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T- wave, multifocal complexes).
- Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
- Uncontrolled systemic hypertension (systolic blood pressure (BP) >180 mm Hg and/or diastolic BP >100 mm Hg despite optimal medical management
- Is in an intensive care setting
- Has an unstable neurological disease (e.g cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent
- Has undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast
- Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:
- Mental illness
- Drug abuse
- Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative serum or urine beta human chorionic gonadotropin results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
- Obesity that limits obtainment of acceptable images
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina of Chapel hill
Chapel Hill, North Carolina, 27599-7510
Vanderbilt University
Nashville, Tennessee, 37232
About this study
Official title: Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD (CEUS CKD)
The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies
Read the detailed description
This is an investigator-initiated, prospective study designed to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) with microbubble contrast agent (perflutren lipid; Definity®) to identify malignancy in patients with kidney disease, a known risk factor for kidney malignancy, in whom a conventional ultrasound (US) shows an indeterminate cystic kidney lesion.
The primary objective of the study is to estimate the sensitivity of CEUS in diagnosing kidney malignancy in patients with a risk factor for kidney malignancy and compare it to the current gold standard test in this patient population. Secondary analysis will include more optimal contrast-enhanced imaging with computed tomography (CT) or magnetic resonance imaging (MRI) in a subset of patients who can receive these studies. The study outcome will lead to immediate clinical application in patients with chronic kidney disease. Given the cost-effectiveness and adverse event profile, it has excellent potential to become established as first line diagnostics in the general patient population as well.
- Conditions
- Chronic Kidney Disease, Cystic Kidney Disease
- Being tested
- Perflutren lipid microsphere
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren lipid microsphereDrug
Also called Definity®, Microbubble contrast agent
Dosing per approved package label
| Study group | Role | What they receive |
|---|---|---|
| Perflutren lipid microsphere | Experimental | Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval Receives: Drug: Perflutren lipid microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lesions With a Change in Radiologist's Evaluation
Lesions will be assessed for change in size, calcification, and septation based on Bosniak criteria (I, II, IIF, III, IV) to determine whether a lesion has progressed, regressed, or is stable.
Measured: Baseline, 1 year
Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy
PRELIMINARY RESULTS of sensitivity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard
Measured: Baseline, 1 year
Specificity of Qualitative Interpretations of CEUS
PRELIMINARY RESULTS of specificity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard
Measured: Baseline, 1 year
Secondary outcomes (2)
Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard
Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard
Measured: Baseline, 1 Year
Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard
Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard
Measured: Baseline, 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion9 Jul 2018
- Study completion9 Jul 2018
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Emily Chang, M.D., Principal investigator, University of North Carolina Kidney Center 7024 Burnett Womack CB #7155 Chapel Hill, NC 27599-7155
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684435
- Sponsor's protocol ID
- 15-1866
- Acronym
- CEUS-CKD
- Status last verified
- Apr 2019
- First submitted
- 3 Feb 2016
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Maisonneuve P, Agodoa L, Gellert R, Stewart JH, Buccianti G, Lowenfels AB, Wolfe RA, Jones E, Disney AP, Briggs D, McCredie M, Boyle P. Cancer in patients on dialysis for end-stage renal disease: an international collaborative study. Lancet. 1999 Jul 10;354(9173):93-9. doi: 10.1016/s0140-6736(99)06154-1.
PubMed 10408483Lindner JR. Microbubbles in medical imaging: current applications and future directions. Nat Rev Drug Discov. 2004 Jun;3(6):527-32. doi: 10.1038/nrd1417. No abstract available.
PubMed 15173842Lind Ramskov K, Thomsen HS. Nephrogenic systemic fibrosis and contrast medium-induced nephropathy: a choice between the devil and the deep blue sea for patients with reduced renal function? Acta Radiol. 2009 Nov;50(9):965-7. doi: 10.3109/02841850903209218. No abstract available.
PubMed 19863403Nicolau C, Bunesch L, Pano B, Salvador R, Ribal MJ, Mallofre C, Sebastia C. Prospective evaluation of CT indeterminate renal masses using US and contrast-enhanced ultrasound. Abdom Imaging. 2015 Mar;40(3):542-51. doi: 10.1007/s00261-014-0237-3.
PubMed 25209216Ascenti G, Mazziotti S, Zimbaro G, Settineri N, Magno C, Melloni D, Caruso R, Scribano E. Complex cystic renal masses: characterization with contrast-enhanced US. Radiology. 2007 Apr;243(1):158-65. doi: 10.1148/radiol.2431051924.
PubMed 17392251
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD (CEUS CKD)
- ClinicalTrials.gov ID
- NCT02684435
- Acronym / sponsor ID
- CEUS-CKD / 15-1866
- Conditions
- Chronic Kidney Disease, Cystic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Vanderbilt University, North Carolina Translational and Clinical Sciences Institute
- Study start
- Feb 2016
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies
Detailed description
This is an investigator-initiated, prospective study designed to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) with microbubble contrast agent (perflutren lipid; Definity®) to identify malignancy in patients with kidney disease, a known risk factor for kidney malignancy, in whom a conventional ultrasound (US) shows an indeterminate cystic kidney lesion.
The primary objective of the study is to estimate the sensitivity of CEUS in diagnosing kidney malignancy in patients with a risk factor for kidney malignancy and compare it to the current gold standard test in this patient population. Secondary analysis will include more optimal contrast-enhanced imaging with computed tomography (CT) or magnetic resonance imaging (MRI) in a subset of patients who can receive these studies. The study outcome will lead to immediate clinical application in patients with chronic kidney disease. Given the cost-effectiveness and adverse event profile, it has excellent potential to become established as first line diagnostics in the general patient population as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perflutren lipid microsphere | Experimental | Drug: Perflutren lipid microsphereActivate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide written informed consent
- Willing to comply with protocol requirements
- At least 18 years of age
- Have kidney disease, defined as either CKD II-VI, determined by estimated glomerular filtration rate (GFR) of <90 and derived from serum creatinine measurements, or albuminuria/proteinuria, determined by albumin to creatinine ratio or protein to creatinine ratio of >30mg/gm, or having received a kidney transplant
- Have at least one kidney lesion identified but incompletely characterized on a non-contrasted US, CT, or MR exam for which the patient's provider recommends follow-up studies or further evaluation with an additional imaging tests.
Key exclusion criteria (19 listed)
- Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)
- Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
- Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome
- Active cardiac disease including any of the following:
- Is in an intensive care setting
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 |
|---|---|---|
| Perflutren lipid microsphereAlso: Definity®, Microbubble contrast agentDosing per approved package label | Drug | Perflutren lipid microsphere |
Primary outcome
Number of Lesions With a Change in Radiologist's Evaluation
Time frame: Baseline, 1 year
Lesions will be assessed for change in size, calcification, and septation based on Bosniak criteria (I, II, IIF, III, IV) to determine whether a lesion has progressed, regressed, or is stable.
Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy
Time frame: Baseline, 1 year
PRELIMINARY RESULTS of sensitivity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard
Specificity of Qualitative Interpretations of CEUS
Time frame: Baseline, 1 year
PRELIMINARY RESULTS of specificity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard
2 secondary outcomes
Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard
Time frame: Baseline, 1 Year
Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard
Time frame: Baseline, 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10408483Maisonneuve P, Agodoa L, Gellert R, Stewart JH, Buccianti G, Lowenfels AB, Wolfe RA, Jones E, Disney AP, Briggs D, McCredie M, Boyle P. Cancer in patients on dialysis for end-stage renal disease: an international collaborative study. Lancet. 1999 Jul 10;354(9173):93-9. doi: 10.1016/s0140-6736(99)06154-1.
- Background: PubMed 15173842Lindner JR. Microbubbles in medical imaging: current applications and future directions. Nat Rev Drug Discov. 2004 Jun;3(6):527-32. doi: 10.1038/nrd1417. No abstract available.
- Background: PubMed 19863403Lind Ramskov K, Thomsen HS. Nephrogenic systemic fibrosis and contrast medium-induced nephropathy: a choice between the devil and the deep blue sea for patients with reduced renal function? Acta Radiol. 2009 Nov;50(9):965-7. doi: 10.3109/02841850903209218. No abstract available.
- Background: PubMed 25209216Nicolau C, Bunesch L, Pano B, Salvador R, Ribal MJ, Mallofre C, Sebastia C. Prospective evaluation of CT indeterminate renal masses using US and contrast-enhanced ultrasound. Abdom Imaging. 2015 Mar;40(3):542-51. doi: 10.1007/s00261-014-0237-3.
- Background: PubMed 17392251Ascenti G, Mazziotti S, Zimbaro G, Settineri N, Magno C, Melloni D, Caruso R, Scribano E. Complex cystic renal masses: characterization with contrast-enhanced US. Radiology. 2007 Apr;243(1):158-65. doi: 10.1148/radiol.2431051924.
- Individual participant dataSharing planned: No
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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.
Emily Chang, M.D. principal investigator
University of North Carolina Kidney Center 7024 Burnett Womack CB #7155 Chapel Hill, NC 27599-7155
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perflutren lipid microsphere in people with Chronic Kidney Disease and Cystic Kidney Disease, run by University of North Carolina, Chapel Hill 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 6 inclusion and 19 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 26 Sep 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2019). 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?
Number of Lesions With a Change in Radiologist's Evaluation (time frame: Baseline, 1 year). The study lists 3 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 NCT02684435, which also lists 5 linked publications.
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 26 Sep 2019.