NCT03820661

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Feb 2019Dec 2026

First Submitted

Initial submission to the registry

January 11, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

7.8 years

First QC Date

January 11, 2019

Last Update Submit

October 7, 2024

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

High Resolution Ultasound

OTHER

Diagnostic high resolution ultrasound pre-operatively and intraoperatively

Device: Ultrasound

Interventions

UltrasoundDEVICE

High resolution ultrasound pre-operatively and intra-operatively

High Resolution Ultasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) Inability or unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Korosh Khalili, MD

    UHN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 29, 2019

Study Start

February 1, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations

CA(1)