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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Gastrointestinal Adenocarcinoma; Pancreas Cancer

Treatments: Diagnostic Test: ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04837833

21-138

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

research ultrasound (rUS1)

Experimental group

Description:

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.

Treatment:

Diagnostic Test: ultrasound