A Subharmonic-Aided Pressure Estimate Technology for Prediction of Response to Systemic Therapy in Gastric Cancer Liver Metastases

NCT07581730 | Not Yet Recruiting

• 1 other identifier: 2026-MS-161
• Study Type: observational
• Target: 107
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gastric 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 gastric 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; Gastric Cancer (GC); Gastric Cancer Metastatic to Liver

Keywords

Gastric 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 gastric cancer liver metastases, examined by LOGIQ E20 ultrasound system.It consists of the peripheral ring of the target lesion is 2mm (dB),a 4mm (dB) peripheral ring around the target lesion,a 6mm peripheral ring (dB) around the target lesion,target lesion overall (dB),central target lesion (dB),liver parenchyma (dB).

  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

Patients with gastric 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+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gastric cancer liver metastases will receive standard first-line chemotherapy.

You may qualify if:

• Age ≥ 18 years.
• Histologically or radiologically confirmed, initially diagnosed and have not undergone any treatment gastric liver metastasis (GCLM).
• 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. 6.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; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Dezhi Zhang associate chief physician

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PI

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share