Liver Metastasis Colon CancerNCT04686942
Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm
An observational study of Liver Metastasis Colon Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Preoperative chemotherapy is often used for patients with colorectal cancer liver metastasis (CLM). Many small CLMs (<=2cm) may disappear after chemotherapy, while most of these are still alive. Ultrasonography (US) is a common imaging modality for the intraoperative detection tumor. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Metastasis Colon Cancer
- What is being tested?
- After sonazoid
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2020to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with one or more liver metastases lesions less than 2cm.
Who may be able to join
- Pathology confirmed colorectal adenocarcinoma
- One or more liver metastases less than 2 cm
- Multidisciplinary team recommend to perform preoperative chemotherapy
- Have baseline EOB-MR before chemotherapy
Who cannot join
- Could not fulfill the criteria of no evidence of disease (NED) after hepatic resection/ablation/radiotherapy
- With other malignancies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Jiliang Qiu, 862087343114, qiujl@sysucc.org.cn
Xuzhi Pan, 862087343009, panxzh@sysucc.org.cn
About this study
Official title: Evaluation of Contrast Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm
Preoperative chemotherapy is often used for patients with colorectal cancer liver metastasis (CLM). Many small CLMs (<=2cm) may disappear after chemotherapy, while most of these are still alive. Ultrasonography (US) is a common imaging modality for the intraoperative detection tumor. Sonazoid is new echo-contrast agent, which is more stable and sensitive for detecting of small tumor. Investigators initially this prospective study to compare the detection performance before and after using sonazoid.
- Conditions
- Liver Metastasis Colon Cancer
- Being tested
- After sonazoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After sonazoidDiagnostic test
0.015ml/mg sonazoid enhanced US to detection of liver metastases.
| Study group | Role | What they receive |
|---|---|---|
| Before sonazoid | US detection liver metastases before sonazoid | |
| After sonazoid | US detection liver metastases after sonazoid Receives: Diagnostic Test: After sonazoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitive of detection tumor
Change of the sensitivity detection liver tumors when using sonazoid enhanced ultrasound
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start17 Dec 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Metastasis Colon CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunfei Yuan, Sun Yat-sen University
- Investigators
- Yunfei Yuan, MD., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686942
- Sponsor's protocol ID
- Sonazoid001
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Contrast Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm
- ClinicalTrials.gov ID
- NCT04686942
- Acronym / sponsor ID
- Sonazoid001
- Conditions
- Liver Metastasis Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 Dec 2020 (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.
Preoperative chemotherapy is often used for patients with colorectal cancer liver metastasis (CLM). Many small CLMs (<=2cm) may disappear after chemotherapy, while most of these are still alive. Ultrasonography (US) is a common imaging modality for the intraoperative detection tumor. Sonazoid is new echo-contrast agent, which is more stable and sensitive for detecting of small tumor. Investigators initially this prospective study to compare the detection performance before and after using sonazoid.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before sonazoid | – | –US detection liver metastases before sonazoid |
| After sonazoid | – | Diagnostic Test: After sonazoidUS detection liver metastases after sonazoid |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with one or more liver metastases lesions less than 2cm.
Key inclusion criteria (4 listed)
- Pathology confirmed colorectal adenocarcinoma
- One or more liver metastases less than 2 cm
- Multidisciplinary team recommend to perform preoperative chemotherapy
- Have baseline EOB-MR before chemotherapy
Key exclusion criteria (2 listed)
- Could not fulfill the criteria of no evidence of disease (NED) after hepatic resection/ablation/radiotherapy
- With other malignancies
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 |
|---|---|---|
| After sonazoid0.015ml/mg sonazoid enhanced US to detection of liver metastases. | Diagnostic test | After sonazoid |
Primary outcome
sensitive of detection tumor
Time frame: 6 months
Change of the sensitivity detection liver tumors when using sonazoid enhanced ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yunfei Yuan, MD. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastasis Colon Cancer, run by Sun Yat-sen University at 1 site in China.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiliang Qiu (862087343114, qiujl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitive of detection tumor (time frame: 6 months). 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 29 Dec 2020.