Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669613
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-07-21
Brief Title:
Contrast Ultrasound Dispersion Imaging CUDI as a Diagnostic Modality in the Diagnosis of Renal Cell Carcinoma
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Contrast Ultrasound Dispersion Imaging CUDI as a Diagnostic Modality in the Diagnosis of Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CUDI-RCC
Brief 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 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 TUe
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 875 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 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 875 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None