Detection of Liver MetastasesOOPSNCT04834596
Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal Adenocarcinoma
An observational study of Detection of Liver Metastases, run by University Hospital, Angers at 1 site in France.
Trial summary
Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Detection of Liver Metastases
- What is being tested?
- retrospectives analysis on hepatic scanner
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2021to 2 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with colorectal cancer
Who may be able to join
- Patients consecutively treated for colorectal cancer a
- Availability of imaging by injected abdominal scanner including at least one portal phase
- Age over 18
Who cannot join
- Patients with treatment of the hepatic nodule by ablation or previous hepatic surgery
- Imaging follow-up <12 months
- Non-interpretable scanner (artefact, injection quality, etc.)
- Patients with more than 10 liver metastases
Trial locations and contacts
1 site in 1 country.
Marie Bost contact
France1 site
UHAngers
Angers, 49933
marie bost, mabost@chu-angers.fr
Anita Paisant
About this study
Official title: Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal
Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer
Read the detailed description
The aim of this study is to evaluate the performance of a software for liver nodule detection in patients with colorectal cancer compared to the consensus of two radiologists analysis.
300 hepatic scanners will be analysed.
- Conditions
- Detection of Liver Metastases
- Being tested
- retrospectives analysis on hepatic scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospectives analysis on hepatic scannerOther
hepatic scanner will be analysed by two radiologist and by the software
| Study group | Role | What they receive |
|---|---|---|
| patients without hepatic metastases | hepatic scanner of 100 patients with colorectal cancer without hepatic metastases will be analysed Receives: Other: retrospectives analysis on hepatic scanner | |
| patients with synchronous hepatic metastases | hepatic scanner of 100 patients with colorectal cancer with synchronous hepatic metastases will be analysed Receives: Other: retrospectives analysis on hepatic scanner | |
| patients with metachronous hepatic metastases | hepatic scanner of 100 patients with colorectal cancer with metachronous hepatic metastases will be analysed Receives: Other: retrospectives analysis on hepatic scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performance of the software for detection of hepatic nodules on CT scan of patients with colorectal cancer compared to a reference constituted by the evaluation established by two radiologists in consensus.
Number of nodules detected by the software compared to the reference method
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 May 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion2 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detection of Liver MetastasesStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834596
- Sponsor's protocol ID
- 2021 OOPS
- Acronym
- OOPS
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal
- ClinicalTrials.gov ID
- NCT04834596
- Acronym / sponsor ID
- OOPS / 2021 OOPS
- Conditions
- Detection of Liver Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 2 May 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 2 May 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer
Detailed description
The aim of this study is to evaluate the performance of a software for liver nodule detection in patients with colorectal cancer compared to the consensus of two radiologists analysis.
300 hepatic scanners will be analysed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients without hepatic metastases | – | Other: retrospectives analysis on hepatic scannerhepatic scanner of 100 patients with colorectal cancer without hepatic metastases will be analysed |
| patients with synchronous hepatic metastases | – | Other: retrospectives analysis on hepatic scannerhepatic scanner of 100 patients with colorectal cancer with synchronous hepatic metastases will be analysed |
| patients with metachronous hepatic metastases | – | Other: retrospectives analysis on hepatic scannerhepatic scanner of 100 patients with colorectal cancer with metachronous hepatic metastases will be analysed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with colorectal cancer
Key inclusion criteria (3 listed)
- Patients consecutively treated for colorectal cancer a
- Availability of imaging by injected abdominal scanner including at least one portal phase
- Age over 18
Key exclusion criteria (4 listed)
- Patients with treatment of the hepatic nodule by ablation or previous hepatic surgery
- Imaging follow-up <12 months
- Non-interpretable scanner (artefact, injection quality, etc.)
- Patients with more than 10 liver metastases
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 |
|---|---|---|
| retrospectives analysis on hepatic scannerhepatic scanner will be analysed by two radiologist and by the software | Other | patients with metachronous hepatic metastases, patients with synchronous hepatic metastases, patients without hepatic metastases |
Primary outcome
To evaluate the performance of the software for detection of hepatic nodules on CT scan of patients with colorectal cancer compared to a reference constituted by the evaluation established by two radiologists in consensus.
Time frame: 1 month
Number of nodules detected by the software compared to the reference method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Marie Bost contact
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 Detection of Liver Metastases, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 4 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 8 Apr 2021. 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 France. 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 Marie Bost (mabost@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the performance of the software for detection of hepatic nodules on CT scan of patients with colorectal cancer compared to a reference constituted by the evaluation established by two radiologists in consensus. (time frame: 1 month). 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 8 Apr 2021.