Kidney CancerCUDI-RCCNCT04669613
Contrast Ultrasound Dispersion Imaging (CUDI) as a Diagnostic Modality in the Diagnosis of Renal Cell Carcinoma
A study testing CUDI in people with Kidney Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Introduction The current limitations of renal cell carcinoma (RCC) imaging form a major deficit in the diagnostic pathway. Contrast Enhanced UltraSound (CEUS) has the potential to improve RCC detection and localization significantly. CEUS image interpretation is however difficult and subjective. 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?
- CUDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Dec 2020to 1 Apr 2021
- 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
- age ≥ 18 years
- signed informed consent
- scheduled for a radical- or partial nephrectomy for the suspicious of a renal tumor.
Who cannot join
- Earlier treatment of renal masses
- History of any clinically evidence of cardiac right-to-left shunts
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
- Is incapable of understanding the language in which the information for the patient is given
- Tumor cannot be visualized/localized on ultrasound imaging
Show all 10Show fewer
- Previous hypersensitivity allergic reactions
- Known allergy of macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol Sodium, Palmitic acid
- Use of dobutamine or conditions suggesting cardiovascular instability where dobutamine is contraindicated.
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC
Amsterdam, North Holland, 1105AZ
Christiaan Widdershoven, Dr., +31622820517, c.v.widdershoven@amsterdamumc.nl
About this study
Introduction The current limitations of renal cell carcinoma (RCC) imaging form a major deficit in the diagnostic pathway. Contrast Enhanced UltraSound (CEUS) has the potential to improve RCC detection and localization significantly. CEUS image interpretation is however difficult and subjective. To overcome these difficulties a CEUS quantification technique, Contrast-enhanced Ultrasound Dispersion Imaging (CUDI), has been developed in cooperation with the Eindhoven University of Technology (TU/e).
Study objective Primary objective: To assess the sensitivity and specificity of CUDI for recognizing malignant tissue in vivo.
Read more
Study population All patients scheduled for a partial or radial nephrectomy in the Amsterdam UMC (Amsterdam Universitair Medische Centra) Study Procedure This study is a prospective in-vivo study in patients scheduled for a partial or radical nephrectomy for a suspicious RCC in which we will perform CEUS imaging. The (partial) nephrectomy is part of standard care for patients with a suspicious lesion in the kidney. The additional ultrasound with infusion of an ultrasound contrast agent during ultrasound scanning is performed for the purpose of the study. CEUS imaging will be performed right before (partial) nephrectomy, with the patient being under general anesthesia. The CEUS and CUDI parametric maps will be interpreted by Investigator A in a blinded fashion with suspicious lesions each delineated. The (partial) nephrectomy will be performed by a qualified urologist, and the analysis of the histological specimens will be performed by a qualified pathologist. Sensitivity and specificity for CUDI will be calculated for all patients receiving a (partial) nephrectomy in which the tissue is sent for pathology.
Benefits Currently, most renal tumors are diagnosed by abdominal US, CT or MRI. Renal tumors are classified as cystic or solid lesions on imaging. The most important criteria for differentiating malignant lesions is the presence of enhancement after administration of contrast for CT or MRI in several different phases (4 phases CT-scan). Enhancement in renal masses is determined by comparing Hounsfield units before and after administration of contrast. A change of 15 or more Hounsfield units demonstrates enhancement. Specificity and sensitivity for detecting RCC are around 75% and 88% for CT, and around 89% and 87.5% for MRI, respectively.
Both CT and MRI can objectify a contrast-enhancing mass, suspicious for RCC, however, they cannot reliably distinguish a benign lesion (such as an oncocytoma or angiomyolipoma) from a malignant renal neoplasm. For that reason, patients are currently undergoing an RTB (renal tumor biopsy) to objectify pathology for deciding if treatment is necessary or not. Recent literature suggests up to 30% benign pathology after partial nephrectomy implicating overtreatment. RTB has been gradually introduced and increasingly used, however, an RTB is not without risks. Bleeding is the most documented complication. Recently even tumor tract seeding has been under discussion. Improving imaging by using CUDI for differentiating benign from malignant lesions instead of performing an RTB could prevent those risks for patients.
Risk assessment There is a small risk of contrast-related adverse events (AE) for participants. After use in millions of patients, AE to the ultrasound contrast agent appear to be transient, mild and rare, and mostly consist of transient alteration of taste, local pain at the injection site and facial or general flush. In some cases, a mild allergic reaction is described. Patients will be informed of the risk during contrast exposure, and it will be described in the patient information file.
- Conditions
- Kidney Cancer
- Being tested
- CUDI
- Keywords
- Ultrasound, CEUS, CUDI, Contrast enhanced ultrasound, Contrast ultrasound dispersion imaging, Kidney cancer, renal cancer, carcinoma
- Medical subject headings
- Kidney Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUDIOther
Also called Contrast ultrasound dispersion imaging
Analysis of the CEUS data by means of Contrast ultrasound dispersion imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Other: CUDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
per-patient RCC detection rates
Measured: through study completion, an average of 1 year
Rate of malignant histology that can be correlated to CUDI-parameters
After receiving both the CUDI-data and the histology data, both will be compared to check if the regions that show different CUDI-parameters match the regions with malignancy in histology
Measured: through study completion, an average of 1 year
Wash out time as a parameter to measure the dispersion of the micro bubbles of the CUDI contrast agent
This is a physical parameter that is quantified from CEUS-data by CUDI. The wash out time is the time that it takes for the micro bubbles to disappear.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
sensitivity of CUDI
Measured: through study completion, an average of 1 year
specificity of CUDI
Measured: through study completion, an average of 1 year
negative predictive value of CUDI
Measured: through study completion, an average of 1 year
positive predictive value of CUDI
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start30 Dec 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669613
- Sponsor's protocol ID
- CUDI-RCC
- Acronym
- CUDI-RCC
- Status last verified
- Dec 2020
- First submitted
- 21 Jul 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ljungberg B, Bensalah K, Canfield S, Dabestani S, Hofmann F, Hora M, Kuczyk MA, Lam T, Marconi L, Merseburger AS, Mulders P, Powles T, Staehler M, Volpe A, Bex A. EAU guidelines on renal cell carcinoma: 2014 update. Eur Urol. 2015 May;67(5):913-24. doi: 10.1016/j.eururo.2015.01.005. Epub 2015 Jan 21.
PubMed 25616710Israel GM, Bosniak MA. Pitfalls in renal mass evaluation and how to avoid them. Radiographics. 2008 Sep-Oct;28(5):1325-38. doi: 10.1148/rg.285075744.
PubMed 18794310Vogel C, Ziegelmuller B, Ljungberg B, Bensalah K, Bex A, Canfield S, Giles RH, Hora M, Kuczyk MA, Merseburger AS, Powles T, Albiges L, Stewart F, Volpe A, Graser A, Schlemmer M, Yuan C, Lam T, Staehler M. Imaging in Suspected Renal-Cell Carcinoma: Systematic Review. Clin Genitourin Cancer. 2019 Apr;17(2):e345-e355. doi: 10.1016/j.clgc.2018.07.024. Epub 2018 Aug 11.
PubMed 30528378Fernando A, Fowler S, O'Brien T; British Association of Urological Surgeons (BAUS). Nephron-sparing surgery across a nation - outcomes from the British Association of Urological Surgeons 2012 national partial nephrectomy audit. BJU Int. 2016 Jun;117(6):874-82. doi: 10.1111/bju.13353. Epub 2015 Nov 18.
PubMed 26469291Marconi L, Dabestani S, Lam TB, Hofmann F, Stewart F, Norrie J, Bex A, Bensalah K, Canfield SE, Hora M, Kuczyk MA, Merseburger AS, Mulders PFA, Powles T, Staehler M, Ljungberg B, Volpe A. Systematic Review and Meta-analysis of Diagnostic Accuracy of Percutaneous Renal Tumour Biopsy. Eur Urol. 2016 Apr;69(4):660-673. doi: 10.1016/j.eururo.2015.07.072. Epub 2015 Aug 29.
PubMed 26323946Macklin PS, Sullivan ME, Tapping CR, Cranston DW, Webster GM, Roberts ISD, Verrill CL, Browning L. Tumour Seeding in the Tract of Percutaneous Renal Tumour Biopsy: A Report on Seven Cases from a UK Tertiary Referral Centre. Eur Urol. 2019 May;75(5):861-867. doi: 10.1016/j.eururo.2018.12.011. Epub 2018 Dec 24.
PubMed 30591353
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Ultrasound Dispersion Imaging (CUDI) as a Diagnostic Modality in the Diagnosis of Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04669613
- Acronym / sponsor ID
- CUDI-RCC / CUDI-RCC
- Conditions
- Kidney Cancer
- Keywords
- Ultrasound, CEUS, CUDI, Contrast enhanced ultrasound, Contrast ultrasound dispersion imaging, Kidney cancer, renal cancer, carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 30 Dec 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 17 Dec 2020 (actual)
- 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.
Introduction The current limitations of renal cell carcinoma (RCC) imaging form a major deficit in the diagnostic pathway. Contrast Enhanced UltraSound (CEUS) has the potential to improve RCC detection and localization significantly. CEUS image interpretation is however difficult and subjective. To overcome these difficulties a CEUS quantification technique, Contrast-enhanced Ultrasound Dispersion Imaging (CUDI), has been developed in cooperation with the Eindhoven University of Technology (TU/e).
Study objective Primary objective: To assess the sensitivity and specificity of CUDI for recognizing malignant tissue in vivo.
Study population All patients scheduled for a partial or radial nephrectomy in the Amsterdam UMC (Amsterdam Universitair Medische Centra) Study Procedure This study is a prospective in-vivo study in patients scheduled for a partial or radical nephrectomy for a suspicious RCC in which we will perform CEUS imaging. The (partial) nephrectomy is part of standard care for patients with a suspicious lesion in the kidney. The additional ultrasound with infusion of an ultrasound contrast agent during ultrasound scanning is performed for the purpose of the study. CEUS imaging will be performed right before (partial) nephrectomy, with the patient being under general anesthesia. The CEUS and CUDI parametric maps will be interpreted by Investigator A in a blinded fashion with suspicious lesions each delineated. The (partial) nephrectomy will be performed by a qualified urologist, and the analysis of the histological specimens will be performed by a qualified pathologist. Sensitivity and specificity for CUDI will be calculated for all patients receiving a (partial) nephrectomy in which the tissue is sent for pathology.
Benefits Currently, most renal tumors are diagnosed by abdominal US, CT or MRI. Renal tumors are classified as cystic or solid lesions on imaging. The most important criteria for differentiating malignant lesions is the presence of enhancement after administration of contrast for CT or MRI in several different phases (4 phases CT-scan). Enhancement in renal masses is determined by comparing Hounsfield units before and after administration of contrast. A change of 15 or more Hounsfield units demonstrates enhancement. Specificity and sensitivity for detecting RCC are around 75% and 88% for CT, and around 89% and 87.5% for MRI, respectively.
Both CT and MRI can objectify a contrast-enhancing mass, suspicious for RCC, however, they cannot reliably distinguish a benign lesion (such as an oncocytoma or angiomyolipoma) from a malignant renal neoplasm. For that reason, patients are currently undergoing an RTB (renal tumor biopsy) to objectify pathology for deciding if treatment is necessary or not. Recent literature suggests up to 30% benign pathology after partial nephrectomy implicating overtreatment. RTB has been gradually introduced and increasingly used, however, an RTB is not without risks. Bleeding is the most documented complication. Recently even tumor tract seeding has been under discussion. Improving imaging by using CUDI for differentiating benign from malignant lesions instead of performing an RTB could prevent those risks for patients.
Risk assessment There is a small risk of contrast-related adverse events (AE) for participants. After use in millions of patients, AE to the ultrasound contrast agent appear to be transient, mild and rare, and mostly consist of transient alteration of taste, local pain at the injection site and facial or general flush. In some cases, a mild allergic reaction is described. Patients will be informed of the risk during contrast exposure, and it will be described in the patient information file.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: CUDI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- signed informed consent
- scheduled for a radical- or partial nephrectomy for the suspicious of a renal tumor.
Key exclusion criteria (10 listed)
- Earlier treatment of renal masses
- History of any clinically evidence of cardiac right-to-left shunts
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
- Is incapable of understanding the language in which the information for the patient is given
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 |
|---|---|---|
| CUDIAlso: Contrast ultrasound dispersion imagingAnalysis of the CEUS data by means of Contrast ultrasound dispersion imaging | Other | Patients |
Primary outcome
per-patient RCC detection rates
Time frame: through study completion, an average of 1 year
Rate of malignant histology that can be correlated to CUDI-parameters
Time frame: through study completion, an average of 1 year
After receiving both the CUDI-data and the histology data, both will be compared to check if the regions that show different CUDI-parameters match the regions with malignancy in histology
Wash out time as a parameter to measure the dispersion of the micro bubbles of the CUDI contrast agent
Time frame: through study completion, an average of 1 year
This is a physical parameter that is quantified from CEUS-data by CUDI. The wash out time is the time that it takes for the micro bubbles to disappear.
4 secondary outcomes
sensitivity of CUDI
Time frame: through study completion, an average of 1 year
specificity of CUDI
Time frame: through study completion, an average of 1 year
negative predictive value of CUDI
Time frame: through study completion, an average of 1 year
positive predictive value of CUDI
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Results publication: PubMed 25616710Ljungberg B, Bensalah K, Canfield S, Dabestani S, Hofmann F, Hora M, Kuczyk MA, Lam T, Marconi L, Merseburger AS, Mulders P, Powles T, Staehler M, Volpe A, Bex A. EAU guidelines on renal cell carcinoma: 2014 update. Eur Urol. 2015 May;67(5):913-24. doi: 10.1016/j.eururo.2015.01.005. Epub 2015 Jan 21.
- Results publication: PubMed 18794310Israel GM, Bosniak MA. Pitfalls in renal mass evaluation and how to avoid them. Radiographics. 2008 Sep-Oct;28(5):1325-38. doi: 10.1148/rg.285075744.
- Results publication: PubMed 30528378Vogel C, Ziegelmuller B, Ljungberg B, Bensalah K, Bex A, Canfield S, Giles RH, Hora M, Kuczyk MA, Merseburger AS, Powles T, Albiges L, Stewart F, Volpe A, Graser A, Schlemmer M, Yuan C, Lam T, Staehler M. Imaging in Suspected Renal-Cell Carcinoma: Systematic Review. Clin Genitourin Cancer. 2019 Apr;17(2):e345-e355. doi: 10.1016/j.clgc.2018.07.024. Epub 2018 Aug 11.
- Results publication: PubMed 26469291Fernando A, Fowler S, O'Brien T; British Association of Urological Surgeons (BAUS). Nephron-sparing surgery across a nation - outcomes from the British Association of Urological Surgeons 2012 national partial nephrectomy audit. BJU Int. 2016 Jun;117(6):874-82. doi: 10.1111/bju.13353. Epub 2015 Nov 18.
- Results publication: PubMed 26323946Marconi L, Dabestani S, Lam TB, Hofmann F, Stewart F, Norrie J, Bex A, Bensalah K, Canfield SE, Hora M, Kuczyk MA, Merseburger AS, Mulders PFA, Powles T, Staehler M, Ljungberg B, Volpe A. Systematic Review and Meta-analysis of Diagnostic Accuracy of Percutaneous Renal Tumour Biopsy. Eur Urol. 2016 Apr;69(4):660-673. doi: 10.1016/j.eururo.2015.07.072. Epub 2015 Aug 29.
- Results publication: PubMed 30591353Macklin PS, Sullivan ME, Tapping CR, Cranston DW, Webster GM, Roberts ISD, Verrill CL, Browning L. Tumour Seeding in the Tract of Percutaneous Renal Tumour Biopsy: A Report on Seven Cases from a UK Tertiary Referral Centre. Eur Urol. 2019 May;75(5):861-867. doi: 10.1016/j.eururo.2018.12.011. Epub 2018 Dec 24.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CUDI in people with Kidney Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 10 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
per-patient RCC detection rates (time frame: through study completion, an average of 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 NCT04669613, which also lists 6 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 17 Dec 2020.