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NCT04837833 Clinical Trial

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

Pancreas Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04837833
Other study ID # 21-138
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 6, 2021
Est. completion date April 6, 2024

Study information
Verified date October 2023
Source Memorial Sloan Kettering Cancer Center
Contact Kinh Gian Do, MD, PhD
Phone 212-639-8591
Email dok@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date April 6, 2024
Est. primary completion date April 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ultrasound
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

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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