Colorectal Liver MetastasisNCT07583381
A Prospective Study of a Subharmonic-Aided Pressure Estimate Technology for Early Prediction of Response to Systemic Therapy in Colorectal Cancer Liver Metastases
A study testing SHAPE in people with Colorectal Liver Metastasis and Liver Neoplasms, run by The First Hospital of Jilin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Liver Metastasis, Liver Neoplasms, Colorectal Neoplasms
- What is being tested?
- SHAPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
This is a single-center, prospective observational study conducted at The First Hospital of Jilin University, designed to investigate the value of contrast-enhanced ultrasound (CEUS) subharmonic imaging in the early prediction of response to first-line chemotherapy in patients with colorectal cancer liver metastases (CRLM).
Currently, treatment response in CRLM is primarily evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), which relies on changes in tumor size measured by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). These assessments typically require 6-8 weeks after treatment initiation, which delays the identification of non-responders and limits opportunities for early treatment modification. There is an unmet clinical need for non-invasive, early biomarkers that can predict response before morphological changes become evident.
Contrast-enhanced ultrasound subharmonic imaging is a radiation-free, real-time modality that specifically detects signals from microbubble contrast agents, providing high-sensitivity assessment of tumor microperfusion. Unlike conventional CEUS, subharmonic imaging suppresses tissue background signals, allowing for more accurate quantification of tumor vascularity and perfusion. This study aims to explore whether quantitative parameters derived from subharmonic time-intensity curves (TIC), obtained early in the course of first-line chemotherapy, can predict subsequent treatment response as defined by RECIST 1.1.
All eligible patients with histologically confirmed CRLM who are scheduled to receive first-line systemic chemotherapy will be enrolled. Patients will undergo baseline subharmonic CEUS examination within one week before the initiation of chemotherapy. Follow-up examinations will be performed after the first cycle of chemotherapy, prior to the standard RECIST 1.1 assessment time point. All examinations will be performed using a GE Logiq E20 ultrasound system equipped with subharmonic imaging software. Regions of interest (ROIs) will be carefully placed within the viable portions of the target liver metastases to generate TIC curves. Quantitative perfusion parameters, including peak intensity (PI), time to peak (TTP), area under the curve (AUC), wash-in rate (WIR), and wash-out rate (WOR), will be extracted and analyzed.
Standard chemotherapy regimens will be administered according to clinical guidelines. Treatment response will be assessed using contrast-enhanced CT or MRI at 8-12 weeks after treatment initiation, classified as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) based on RECIST 1.1 criteria. The correlation between early changes in subharmonic CEUS parameters and the final treatment response will be evaluated using statistical methods, including receiver operating characteristic (ROC) curve analysis to determine the predictive performance of each parameter.
The primary objective is to identify early subharmonic CEUS perfusion parameters that can predict favorable response (CR/PR) versus non-response (SD/PD) to first-line chemotherapy. The findings of this study may provide a novel, non-invasive imaging biomarker for the early prediction of treatment response in CRLM patients, enabling timely treatment adjustments, minimizing unnecessary toxicity, and potentially improving clinical outcomes.
- Being tested
- SHAPE
- Keywords
- Colorectal cancer liver metastasis, Contrast-enhanced ultrasound, Subharmonic imaging, Chemotherapy response prediction, Early treatment response, Perfusion imaging
- Medical subject headings
- Liver Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAPEDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: SHAPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks after systemic therapy initiation
Secondary outcomes (1)
Objective Response (ORR)
Tumor response of colorectal cancer liver metastases assessed by contrast-enhanced CT or MRI according to RECIST 1.1 criteria.
Measured: 8 weeks after the initiation of systemic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasisStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dezhi Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583381
- Sponsor's protocol ID
- 2025-MS-556
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to patient privacy protection requirements and institutional data management policies. Data will only be available to the study investigators and authorized personnel involved in this research
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of a Subharmonic-Aided Pressure Estimate Technology for Early Prediction of Response to Systemic Therapy in Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT07583381
- Acronym / sponsor ID
- 2025-MS-556
- Keywords
- Colorectal cancer liver metastasis, Contrast-enhanced ultrasound, Subharmonic imaging, Chemotherapy response prediction, Early treatment response, Perfusion imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, prospective observational study conducted at The First Hospital of Jilin University, designed to investigate the value of contrast-enhanced ultrasound (CEUS) subharmonic imaging in the early prediction of response to first-line chemotherapy in patients with colorectal cancer liver metastases (CRLM).
Currently, treatment response in CRLM is primarily evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), which relies on changes in tumor size measured by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). These assessments typically require 6-8 weeks after treatment initiation, which delays the identification of non-responders and limits opportunities for early treatment modification. There is an unmet clinical need for non-invasive, early biomarkers that can predict response before morphological changes become evident.
Contrast-enhanced ultrasound subharmonic imaging is a radiation-free, real-time modality that specifically detects signals from microbubble contrast agents, providing high-sensitivity assessment of tumor microperfusion. Unlike conventional CEUS, subharmonic imaging suppresses tissue background signals, allowing for more accurate quantification of tumor vascularity and perfusion. This study aims to explore whether quantitative parameters derived from subharmonic time-intensity curves (TIC), obtained early in the course of first-line chemotherapy, can predict subsequent treatment response as defined by RECIST 1.1.
All eligible patients with histologically confirmed CRLM who are scheduled to receive first-line systemic chemotherapy will be enrolled. Patients will undergo baseline subharmonic CEUS examination within one week before the initiation of chemotherapy. Follow-up examinations will be performed after the first cycle of chemotherapy, prior to the standard RECIST 1.1 assessment time point. All examinations will be performed using a GE Logiq E20 ultrasound system equipped with subharmonic imaging software. Regions of interest (ROIs) will be carefully placed within the viable portions of the target liver metastases to generate TIC curves. Quantitative perfusion parameters, including peak intensity (PI), time to peak (TTP), area under the curve (AUC), wash-in rate (WIR), and wash-out rate (WOR), will be extracted and analyzed.
Standard chemotherapy regimens will be administered according to clinical guidelines. Treatment response will be assessed using contrast-enhanced CT or MRI at 8-12 weeks after treatment initiation, classified as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) based on RECIST 1.1 criteria. The correlation between early changes in subharmonic CEUS parameters and the final treatment response will be evaluated using statistical methods, including receiver operating characteristic (ROC) curve analysis to determine the predictive performance of each parameter.
The primary objective is to identify early subharmonic CEUS perfusion parameters that can predict favorable response (CR/PR) versus non-response (SD/PD) to first-line chemotherapy. The findings of this study may provide a novel, non-invasive imaging biomarker for the early prediction of treatment response in CRLM patients, enabling timely treatment adjustments, minimizing unnecessary toxicity, and potentially improving clinical outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subharmonic Ultrasound Assessment Group | Experimental | Diagnostic Test: SHAPEPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHAPEUsing 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 | Diagnostic test | Subharmonic Ultrasound Assessment Group |
Primary outcome
Absolute change in subharmonic perfusion pressure parameters
Time frame: Baseline and 4 weeks after systemic therapy initiation
Absolute change in subharmonic ultrasound-derived perfusion pressure parameters of colorectal cancer liver metastases, examined by LOGIQ E20 ultrasound system.
1 secondary outcome
Objective Response (ORR)
Time frame: 8 weeks after the initiation of systemic therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to patient privacy protection requirements and institutional data management policies. Data will only be available to the study investigators and authorized personnel involved in this research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing SHAPE in people with Colorectal Liver Metastasis and Liver Neoplasms, run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dezhi Zhang associate chief physician, MD (+86 0431-88782190, dezhi@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in subharmonic perfusion pressure parameters (time frame: Baseline and 4 weeks after systemic therapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.