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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms

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

External Links

•   Memorial Sloan Kettering Cancer Center