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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04837833

Enrollment

Registered

2021-04-08

Start date

2021-04-06

Completion date

2027-04-06

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Adenocarcinoma, Pancreas Cancer

Keywords

Sonographic Assessment, Tumor Volumes for Response, 21-138

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.

Interventions

DIAGNOSTIC_TESTultrasound

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKinh Gian Do, MD, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026