About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with gastric cancer liver metastases will receive standard first-line chemotherapy.
Trial design
Case-only
Prospective
Treatments tested in this trial
SHAPE
Diagnostic testUsing 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Objective Response (ORR)
Tumor response of gastric cancer liver metastases assessed by contrast-enhanced CT or MRI according to RECIST 1.1 criteria.
Other outcomes
Correlation between ultrasound parameters and tumor response
To analyze the correlation between early subharmonic ultrasound parameters and tumor response assessed by RECIST 1.1 criteria.
Locations
Sponsors and contacts
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