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

Starting soon · Not applicable

Conditions studied: Colorectal Liver Metastasis, Liver Neoplasms, Colorectal Neoplasms

In brief

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 facts

Study ID

NCT07583381

Run by

The First Hospital of Jilin University

People needed

107

Starts

2026-06-01

Expected to finish

2027-12-31

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Histologically or radiologically confirmed, initially diagnosed and have not undergone any treatment colorectal liver metastasis (CRLM).
• Lesion size ≤ 6 cm (preferably located adjacent to major anatomical structures such as large vessels or bile ducts).
• Lesion depth ≤ 10 cm on ultrasound imaging.
• Planned to receive guideline-recommended first-line systemic therapy.
• The target lesion has not undergone any prior systemic or local treatment, including surgery, ablation, embolization, targeted therapy, or investigational agents, before enrollment.
• Willingness to provide written informed consent.

You may not qualify if…

• Inability to cooperate with contrast-enhanced ultrasound or subharmonic imaging examinations (e.g., dyspnea when lying supine or excessive out-of-plane motion).
• Know or suspected allergy to the contrast agent or other contraindications to its use.
• Target lesion not previously evaluated or managed according to standard systemic treatment protocols.
• Clinically unstable condition, advanced-stage disease, or patients with an unpredictable clinical course that may affect treatment tolerance or follow-up.
• Pregnant or breastfeeding women.
• Inability to understand or comply with the study protocol, including the requirement to complete follow-up visits and examinations.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.