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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04837833

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer Gastrointestinal Adenocarcinoma	Diagnostic Test: ultrasound	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 6, 2021

Anticipated Primary Completion Date :

Apr 6, 2023

Anticipated Study Completion Date :

Apr 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: research ultrasound (rUS1) Participants will undergo research ultrasound (rUS1) within three 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.	Diagnostic Test: ultrasound Participants will undergo research ultrasound (rUS1) within three 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

Arm

Intervention/Treatment

Experimental: research ultrasound (rUS1)

Participants will undergo research ultrasound (rUS1) within three 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.

Diagnostic Test: ultrasound

Participants will undergo research ultrasound (rUS1) within three 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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Richard K.G. Do, MD, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT04837833

Other Study ID Numbers:

21-138

First Posted:

Apr 8, 2021

Last Update Posted:

May 13, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Memorial Sloan Kettering Cancer Center

Sonographic Assessment

Tumor Volumes for Response

21-138

Additional relevant MeSH terms:

Adenocarcinoma

Pancreatic Neoplasms

Study Results

No Results Posted as of May 13, 2022