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

Overview

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.

Full Title of Study: “Machine Learning Approach to Sonographic Assessment of Tumor Volumes for Response Assessment in Patients With Pancreatic Cancer: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 6, 2023

Interventions

  • Diagnostic Test: ultrasound
    • Participants will undergo research ultrasound (rUS1) within two days of their routine CECT scan. A subset of participants 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

Arms, Groups and Cohorts

  • Experimental: research ultrasound (rUS1)
    • Participants will undergo research ultrasound (rUS1) within two days of their routine contrast enhanced CT scan (CECT). A subset of participants 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.

Clinical Trial Outcome Measures

Primary Measures

  • measurement differences between ultrasound tumor volumes
    • Time Frame: 1 year
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female patients, 18 years of age or older – Confirmed diagnosis of pancreatic 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard K.G. Do, MD, PhD, Principal Investigator, Memorial Sloan Kettering Cancer Center
  • Overall Contact(s)
    • Richard K.G. Do, MD, PhD, 212-639-8591, dok@mskcc.org

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.