High Resolution Ultrasound in Pancreatic Ductal Adenocarc... | NCT03820661

Studies
High Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma

NCT03820661

Sponsor

University Health Network, Toronto

Status

Active, not recruiting

Last Update Posted

Oct 10, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

Ultrasound

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jan 11, 2019

First Submission Date that Met QC Criteria

Jan 25, 2019

First Posted Date

Jan 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2024

Last Update Posted Date

Oct 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pancreatic cancer patients at UHN who have had a CT at UHN and have surgery planned will undergo a high resolution ultrasound pre-operatively and intra-operatively. This study is being done to see if using high resolution ultrasound before and during surgery will help the doctors accurately diagnose pancreatic ductal adenocarcinoma and identify if the disease has spread to other areas of the body.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Resolution Ultasound	Other	Diagnostic high resolution ultrasound pre-operatively and intraoperatively	Device: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Device	High resolution ultrasound pre-operatively and intra-operatively	High Resolution Ultasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
High-resolution U/S will be used to measure vascular invasion and regional lymph node metastases in PDAC	The U/S results will be compared to pre-operative CT scan to help determine the diagnostic effectiveness of High Resolution US	within 2 weeks of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females > 18 y
PDAC diagnosed by typical imaging findings or pathology
Scheduled for surgical resection
Contrast enhanced CT scan performed locally at UHN

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Korosh Khalili, MD	UHN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network		Toronto	Ontario	M5G 2C4	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided