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
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2021
CompletedStudy Start
First participant enrolled
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 6, 2027
April 27, 2026
April 1, 2026
6 years
April 6, 2021
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
research ultrasound (rUS1)
EXPERIMENTALParticipants 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kinh Gian Do, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 8, 2021
Study Start
April 6, 2021
Primary Completion (Estimated)
April 6, 2027
Study Completion (Estimated)
April 6, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.