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

NCT07583381 | Not Yet Recruiting

• 1 other identifier: 2025-MS-556
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Neoplasms; Colorectal Neoplasms; Colorectal Liver Metastasis

Keywords

Colorectal cancer liver metastasis; Contrast-enhanced ultrasound; Subharmonic imaging; Chemotherapy response prediction; Early treatment response; Perfusion imaging

Outcome Measures

Primary Outcomes (1)

• Absolute change in subharmonic perfusion pressure parameters

  Absolute change in subharmonic ultrasound-derived perfusion pressure parameters of colorectal cancer liver metastases, examined by LOGIQ E20 ultrasound system.

  Baseline and 4 weeks after systemic therapy initiation

Secondary Outcomes (1)

• Objective Response (ORR)

  8 weeks after the initiation of systemic therapy

Other Outcomes (1)

• Correlation between ultrasound parameters and tumor response

  Baseline, 4 weeks and 8 weeks after systemic therapy

Study Arms (1)

Subharmonic Ultrasound Assessment Group

EXPERIMENTAL

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

Diagnostic Test: SHAPE

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

Subharmonic Ultrasound Assessment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Liver Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Dezhi Zhang associate chief physician, MD

CONTACT

+86 0431-88782190; dezhi@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PI

Model Details: This is a single-arm observational study. All enrolled patients will receive standard first-line chemotherapy for colorectal cancer liver metastases, and will undergo contrast-enhanced subharmonic ultrasound examinations to evaluate treatment response.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share