An Ultrasound Imaging Technique to Measure Tumors in People With Pancreatic Ductal Adenocarcinoma (PDAC) or Gastrointestinal (GI) Adenocarcinoma

Study Overview
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Brief Summary
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The purpose of this study is to see if ultrasound images that are analyzed by a special computer program can be used to measure the size of PDAC tumors in the liver as accurately as CT scans that involve contrast material (also called contrast-enhanced CT scans). All participants in this study will have pancreatic ductal adenocarcinoma (PDAC) that has spread (metastasized) to the liver, and all participants will be scheduled for a routine CT scan that will measure their cancer.

Official Title
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Machine Learning Approach to Sonographic Assessment of Tumor Volumes for Response Assessment in Patients With Pancreas or Gastrointestinal Adenocarcinoma: A Pilot Study

Conditions
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Pancreas Cancer, Gastrointestinal Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients, 18 years of age or older Confirmed diagnosis of PDAC or GI tract adenocarcinoma metastatic to liver Scheduled for imaging with contrast enhanced CT Exclusion Criteria: Inability to tolerate intravenous contrast medium All liver metastases ≤ 10 mm in maximal diameter on the contrast enhanced CT used for comparison to the planned research ultrasound Multiple confluent liver metastases or tumor burden > 50% of the liver as estimated by a radiologist

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: research ultrasound (rUS1)<br>Participants will undergo research ultrasound (rUS1) within three days of their routine contrast enhanced CT scan (CECT). A subset of participants (up to 10) will undergo a second research US (rUS2) at 3-4 weeks after rUS1 and at least one month prior to the next planned clinical CECT. | Diagnostic Test: ultrasound<br>* Participants will undergo research ultrasound (rUS1) within three days of their routine CECT scan. A subset of participants (up to 10) will undergo a second research US (rUS2) at 3-4 weeks after rUS1 and at least one month prior to the next planned clinical CECT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement differences between ultrasound tumor volumes | Measure the range of volumetric changes of liver metastases observed between rUS1 and rUS2. We will correlate the rate (%) of tumor volumetric change between the rUS1 and rUS2 to the rate of change between the two CECT. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sonographic Assessment, Tumor Volumes for Response, 21-138