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: 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
- 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
- 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
- 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
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Provider of Information About this Clinical Study
- 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, email@example.com
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