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

Not Applicable

Active, not recruiting

• Conditions: Pancreas Cancer; Gastrointestinal Adenocarcinoma
• Interventions: Diagnostic Test: ultrasound

• Registration Number: NCT04837833
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-06
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Primary Completion: 2026-04-06
• Study Completion: 2026-04-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
research ultrasound (rUS1)	ultrasound	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.

Primary Outcome Measures

Name	Time	Method
measurement differences between ultrasound tumor volumes	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States