Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977777
Status:
RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-03-16
Brief Title:
Contrast-enhanced Ultrasound and Pancreatic Lesions
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Characterization of Pancreatic Lesions Using Dynamic Contrast-enhanced Ultrasound
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
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:
None
Brief Summary:
The characterization of pancreatic lesions is one of the fundamental steps in the management of pancreatic neoplastic diseases In terms of a subjective assessment of vascular enhancement in the various examination stages the use of contrast-enhanced ultrasonography CEUS in the study of pancreatic neoplastic disease has been thoroughly investigated Technology advancements have enabled the development of software that can perform an objective study of the parameters of vascular enhancement and their variations during dynamic CEUS DCEUS Currently the paucity of data regarding the characterization of pancreatic lesions trough DCEUS limit the definition of its role in pancreatic disease The main purpose of this study is to employ the knowledge in this field trough the characterization of focal pancreatic lesions using DCEUS
Detailed Description:
Pancreatic cancer is currently one of the most prevalent malignant neoplasms characterized by an increasing prevalence and a high mortality and lethality rate It is the seventh most common malignant tumor in the general population the fourth most deadly in both sexes with a 5-year survival rate of approximately 9 The lack of an early diagnostic tool and the absence of effective treatments for advanced-stage disease are the major contributors to this poor prognosis
The diagnosis of pancreatic cancer is based on the results of multiple examinations including various imaging modalities until the histological diagnosis is obtained through biopsy Transabdominal ultrasound US computed tomography CT magnetic resonance imaging MRI and endoscopic ultrasound EUS are performed to detect and stage pancreas cancer in resectable borderline locally advanced and metastatic Hence the differential diagnosis and characterization of solid pancreatic tumors represent a crucial step in identifying a suitable therapeutic strategy
Transabdominal US is frequently used as a first-line diagnostic tool for patients with suspected pancreatic diseases The main limitation of transabdominal US is the low accuracy in the differential diagnosis between malignant and benign solid lesions and considering malignant lesions between the different pancreatic tumors adenocarcinomas neuroendocrine tumors carcinosarcomas lymphomas since all these masses appear as hypoechoic formations
The introduction of ultrasound contrast agent UCA has significantly improved the diagnostic abilities of conventional ultrasound and contrast enhanced ultrasound CEUS has been widely implemented in clinical practice because of the enormous quantity of information it provides along with its low cost reproducibility minimal invasiveness and safety of the UCA In the detection of pancreatic cancer contrast enhanced ultrasound CEUS achieve a sensitivity and specificity of 92 and 76 respectively The European Federation for Ultrasound in Medicine and Biology EFSUMB has recently defined the importance of contrast-enhanced ultrasonography CEUS in the diagnosis of pancreatic disease supporting its use to characterize B-mode-identified pancreatic solid lesions
Despite its numerous advantages one of the most significant limitations of CEUS is the subjective evaluation of contrast enhancement related behavior of tissues examined In recent years one of the methods explored to overcome this limitation has been the Dynamic CEUS DCEUS which allow the quantitative analysis of UCA-kinetics in a specific region of interest ROI It consists of measuring the average intensity of a ROI following a bolus injection of UCA and generating a time-intensity curve TIC Then multiple parameters are derived from the TIC to quantitatively characterize the different stages of the wash-in and wash-out phases These parameters can be divided into three categories time parameters intensity parameters and area under the curve AUC
Very few evidence has been published concerning the use of DCEUS in the characterization of pancreatic lesions Kersting et al performed DCEUS in sixty undetermined pancreatic lesions then histologically characterized as pancreatic ductal adenocarcinoma PDAC n 45 or inflammatory lesion in chronic pancreatitis CP n 15 The grouped analysis of TICs showed a significant prolonged time to peak and arrival time for PDAC then CP compared with normal pancreatic tissue In another study DOnofrio et al performed a quantitative perfusion analysis of ten prospectively enrolled patients with suspected pancreatic ductal adenocarcinoma PDAC The results showed a significant difference in peak of enhancement and ascending curve between PDAC and normal pancreatic parenchyma providing an objective quantification of enhancement for the assessment of pancreatic lesion These findings suggest a potential usefulness of DCEUS in characterizing and differentiating focal pancreatic lesions However the amount of data currently available in the published studies is limited
The main purpose of this study is to employ the knowledge in this field trough the characterization of focal pancreatic lesions using DCEUS
Materials and methods Fifty patients with a transabdominal US diagnosis of a pancreatic lesion who receive CEUS and a subsequent biopsy for histologic characterization will be enrolled in this prospective study Inclusion criteria are at least 18 years of age at least one pancreatic lesion visible in B-mode US and investigated trough CEUS and provide written consent Exclusion criteria comprise less than 18 years of age and absence of informed consent
All patients enrolled in this study will be fasting for at least 8 hours before CEUS examinations During the B-mode ultrasound location size and echogenicity of lesion detected will be assess According to CEUS guideline after the bolus injection of 24 ml sulfur hexafluoride microbubbles SonoVueLumason Bracco via peripheral upper limb vein and followed by a 5-10 ml saline flush the enhancement features of the lesion during arterial portal and late phases will be recorded and examined Clinical and laboratoristic data will be also recorded After examination TICs will be obtained and the following quantitative parameters will be described peak enhancement time to peak area under the curve mean transit time and the slope of wash-in curve
Statistical analysis This is monocenter prospective non-pharmacological trial Nominal or ordinal variables will be presented as frequencies and percentages Mean standard deviation median and 95 confidence intervals will be calculated for continuous variables Comparison between meansmedian will be investigated with Mann-Whitney test A p value 005 will be considered statistically significant
The diagnosis of pancreatic cancer is based on the results of multiple examinations including various imaging modalities until the histological diagnosis is obtained through biopsy Transabdominal ultrasound US computed tomography CT magnetic resonance imaging MRI and endoscopic ultrasound EUS are performed to detect and stage pancreas cancer in resectable borderline locally advanced and metastatic Hence the differential diagnosis and characterization of solid pancreatic tumors represent a crucial step in identifying a suitable therapeutic strategy
Transabdominal US is frequently used as a first-line diagnostic tool for patients with suspected pancreatic diseases The main limitation of transabdominal US is the low accuracy in the differential diagnosis between malignant and benign solid lesions and considering malignant lesions between the different pancreatic tumors adenocarcinomas neuroendocrine tumors carcinosarcomas lymphomas since all these masses appear as hypoechoic formations
The introduction of ultrasound contrast agent UCA has significantly improved the diagnostic abilities of conventional ultrasound and contrast enhanced ultrasound CEUS has been widely implemented in clinical practice because of the enormous quantity of information it provides along with its low cost reproducibility minimal invasiveness and safety of the UCA In the detection of pancreatic cancer contrast enhanced ultrasound CEUS achieve a sensitivity and specificity of 92 and 76 respectively The European Federation for Ultrasound in Medicine and Biology EFSUMB has recently defined the importance of contrast-enhanced ultrasonography CEUS in the diagnosis of pancreatic disease supporting its use to characterize B-mode-identified pancreatic solid lesions
Despite its numerous advantages one of the most significant limitations of CEUS is the subjective evaluation of contrast enhancement related behavior of tissues examined In recent years one of the methods explored to overcome this limitation has been the Dynamic CEUS DCEUS which allow the quantitative analysis of UCA-kinetics in a specific region of interest ROI It consists of measuring the average intensity of a ROI following a bolus injection of UCA and generating a time-intensity curve TIC Then multiple parameters are derived from the TIC to quantitatively characterize the different stages of the wash-in and wash-out phases These parameters can be divided into three categories time parameters intensity parameters and area under the curve AUC
Very few evidence has been published concerning the use of DCEUS in the characterization of pancreatic lesions Kersting et al performed DCEUS in sixty undetermined pancreatic lesions then histologically characterized as pancreatic ductal adenocarcinoma PDAC n 45 or inflammatory lesion in chronic pancreatitis CP n 15 The grouped analysis of TICs showed a significant prolonged time to peak and arrival time for PDAC then CP compared with normal pancreatic tissue In another study DOnofrio et al performed a quantitative perfusion analysis of ten prospectively enrolled patients with suspected pancreatic ductal adenocarcinoma PDAC The results showed a significant difference in peak of enhancement and ascending curve between PDAC and normal pancreatic parenchyma providing an objective quantification of enhancement for the assessment of pancreatic lesion These findings suggest a potential usefulness of DCEUS in characterizing and differentiating focal pancreatic lesions However the amount of data currently available in the published studies is limited
The main purpose of this study is to employ the knowledge in this field trough the characterization of focal pancreatic lesions using DCEUS
Materials and methods Fifty patients with a transabdominal US diagnosis of a pancreatic lesion who receive CEUS and a subsequent biopsy for histologic characterization will be enrolled in this prospective study Inclusion criteria are at least 18 years of age at least one pancreatic lesion visible in B-mode US and investigated trough CEUS and provide written consent Exclusion criteria comprise less than 18 years of age and absence of informed consent
All patients enrolled in this study will be fasting for at least 8 hours before CEUS examinations During the B-mode ultrasound location size and echogenicity of lesion detected will be assess According to CEUS guideline after the bolus injection of 24 ml sulfur hexafluoride microbubbles SonoVueLumason Bracco via peripheral upper limb vein and followed by a 5-10 ml saline flush the enhancement features of the lesion during arterial portal and late phases will be recorded and examined Clinical and laboratoristic data will be also recorded After examination TICs will be obtained and the following quantitative parameters will be described peak enhancement time to peak area under the curve mean transit time and the slope of wash-in curve
Statistical analysis This is monocenter prospective non-pharmacological trial Nominal or ordinal variables will be presented as frequencies and percentages Mean standard deviation median and 95 confidence intervals will be calculated for continuous variables Comparison between meansmedian will be investigated with Mann-Whitney test A p value 005 will be considered statistically significant
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