Contrast-enhanced Ultrasound and Pancreatic Lesions
Characterization of Pancreatic Lesions Using Dynamic Contrast-enhanced Ultrasound
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pancreatic-cancer
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2022
CompletedFirst Submitted
Initial submission to the registry
March 16, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedAugust 4, 2023
August 1, 2023
2 years
March 16, 2023
August 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
diagnostic agreement between contrast-enhanced ultrasound and histology
to quantify peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients with pancreatic lesions, stratified according to the histologic exam of pancreatic lesions
within 3 months from enrollement
Study Arms (1)
Patients
EXPERIMENTALPatients affected by focal pancreatic lesions
Interventions
Contrast- enahnched ultrasound is performed on target pancreatic lesion
Eligibility Criteria
You may qualify if:
- written informed consent
- at least 18 years of age
- at least one pancreatic lesion visible in B-mode US and investigated trough CEUS
You may not qualify if:
- less than 18 years of age
- absence of informed consent
- knowm allergy to ultrasound contrast agent
- hearth failure
- pregnancy
- lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Gemelli IRCCS
Roma, 00168, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
March 16, 2023
First Posted
August 4, 2023
Study Start
November 7, 2022
Primary Completion
November 1, 2024
Study Completion
June 1, 2025
Last Updated
August 4, 2023
Record last verified: 2023-08