A Prospective Study of a Subharmonic-Aided Pressure Estimate Technology for Early Prediction of Response to Systemic Therapy in Colorectal Cancer Liver Metastases

Sponsor
The First Hospital of Jilin University
Study ID
NCT07583381
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHAPE — DIAGNOSTIC_TEST
    Using the ultrasound probe, perform a full-liver sweep to identify the target lesion. Save both static and dynamic two-dimensional images. Optimize all machine parameters, switch to the subharmonic imaging mode, and standardize the MI settings. Record a 5-second video every 30 seconds, repeating this process three times. Finally, perform TIC analysis

Study Details

Colorectal cancer is a common type of cancer that often spreads to the liver. When cancer spreads to the liver, treatment becomes very difficult. Many patients will undergo chemotherapy to shrink the tumor. Currently, doctors use CT or MRI scans to assess the effect of chemotherapy, but these examinations usually take about 2 months to show changes in the size of the tumor. The purpose of this study is to test whether a special type of ultrasound technology called "contrast-enhanced subharmonic ultrasound" can help doctors determine earlier whether chemotherapy is effective compared to conventional scans. This ultrasound detection does not use radiation and can display the blood perfusion status inside liver tumors. We will observe the changes in blood flow perfusion inside the tumor before the start of treatment and after 1-2 chemotherapy cycles to see if these changes can predict whether chemotherapy will be effective in the future. If this test is effective, it will help doctors adjust the treatment plan more quickly, which may improve the treatment effect for colon cancer patients whose cancer cells have spread to the liver, and also help identify patients who are not responding to chemotherapy as early as possible, reducing the side effects and economic burden of patients.

Key Dates

First listed
May 13, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
107 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Subharmonic Ultrasound Assessment Group
    Patients with colorectal cancer liver metastases will receive standard first-line chemotherapy. In addition, they will undergo contrast-enhanced subharmonic ultrasound examinations at baseline and after the first chemotherapy

Primary Outcome Measure

Absolute change in subharmonic perfusion pressure parameters [ Time Frame: Baseline and 4 weeks after systemic therapy initiation ]

Central Contacts

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