Colo-rectal CancerNCT06024837
Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study
An observational study of Colo-rectal Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Spectral CT is a rapidly expanding imaging modality that allows a reduction in iodine dose and irradiation compared to conventional scanning. It uses the difference in attenuation of the material according to the two different energy levels of the incident x-ray beams. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- CT Images
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2023to Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with synchronous or metachronous peritoneal and/or liver metastases of colorectal cancer with curative surgical plans.
Who may be able to join
- Patients followed for colorectal cancer with synchronous or metachronous liver metastases and/or peritoneal carcinosis
- Patients with a curative surgical resection plan
Who cannot join
- Patients with non-metastatic colorectal cancer
- Patients treated with chemotherapy without surgical plans
- Patients with colorectal cancer with extra-hepatic and extra-peritoneal metastases alone (e.g. lung, bone)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne, 42000
Rémi GRANGE, MD, (0)477828963 ext. +33, remi.grange@chu-st-etienne.fr
Sylvain GRANGE, MD, (0)477829066 ext. +33, sylvain.grange@chu-st-etienne.fr
About this study
Spectral CT is a rapidly expanding imaging modality that allows a reduction in iodine dose and irradiation compared to conventional scanning. It uses the difference in attenuation of the material according to the two different energy levels of the incident x-ray beams. The dual-energy scanner has a wide range of clinical applications, particularly in abdominal imaging.
Read the detailed description
First of all, the virtual creation of mono-energy images between 40 and 140 keV has shown subjective and objective improvement of tumor detection of hypovascular lesions using low energies (40keV). It has been shown to be of interest in vascular and cardiac imaging, and to reduce artefacts in bone imaging. However, its performance in oncology analysis has been little studied. The selection of patients for peritoneal and hepatic carcinosis surgery is fundamental, as surgery allows a prolongation of survival, but are associated with a non-negligible morbi-mortality rate.
Spectral CT provides improved detection of peritoneal carcinosis and liver metastases of colorectal cancer compared to conventional CT acquisition.
- Conditions
- Colo-rectal Cancer
- Being tested
- CT Images
- Keywords
- Colo-rectal cancer, spectral CT scan, liver metastases, peritoneal carcinosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ImagesOther
Analysis of CT images of peritoneal and/or liver metastases from colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Patients with Colo-rectal Cancer | Patients with Colo-rectal Cancer will be included. Receives: Other: CT Images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of peritoneal lesion mapping between spectral scanning and conventional scanning
Comparison of peritoneal lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).
Measured: Year : 1
Comparison of hepatic lesion mapping between spectral scanning and conventional scanning
Comparison of hepatic lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).
Measured: Year : 1
Secondary outcomes (2)
Evaluation of response to chemotherapy in RECIST 1.1
Collection of demographic, biological and surgical data.
Measured: Year : 1
Evaluation of response to chemotherapy in Radiomics
Collection of demographic, biological and surgical data.
Measured: Year : 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start7 Jun 2023
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémi GRANGE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024837
- Sponsor's protocol ID
- IRBN1162022/CHUSTE
- Status last verified
- Sep 2024
- First submitted
- 21 Aug 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT06024837
- Acronym / sponsor ID
- IRBN1162022/CHUSTE
- Conditions
- Colo-rectal Cancer
- Keywords
- Colo-rectal cancer, spectral CT scan, liver metastases, peritoneal carcinosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 Sep 2023 (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.
Spectral CT is a rapidly expanding imaging modality that allows a reduction in iodine dose and irradiation compared to conventional scanning. It uses the difference in attenuation of the material according to the two different energy levels of the incident x-ray beams. The dual-energy scanner has a wide range of clinical applications, particularly in abdominal imaging.
Detailed description
First of all, the virtual creation of mono-energy images between 40 and 140 keV has shown subjective and objective improvement of tumor detection of hypovascular lesions using low energies (40keV). It has been shown to be of interest in vascular and cardiac imaging, and to reduce artefacts in bone imaging. However, its performance in oncology analysis has been little studied. The selection of patients for peritoneal and hepatic carcinosis surgery is fundamental, as surgery allows a prolongation of survival, but are associated with a non-negligible morbi-mortality rate.
Spectral CT provides improved detection of peritoneal carcinosis and liver metastases of colorectal cancer compared to conventional CT acquisition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Colo-rectal Cancer | – | Other: CT ImagesPatients with Colo-rectal Cancer will be included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with synchronous or metachronous peritoneal and/or liver metastases of colorectal cancer with curative surgical plans.
Key inclusion criteria (2 listed)
- Patients followed for colorectal cancer with synchronous or metachronous liver metastases and/or peritoneal carcinosis
- Patients with a curative surgical resection plan
Key exclusion criteria (3 listed)
- Patients with non-metastatic colorectal cancer
- Patients treated with chemotherapy without surgical plans
- Patients with colorectal cancer with extra-hepatic and extra-peritoneal metastases alone (e.g. lung, bone)
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 |
|---|---|---|
| CT ImagesAnalysis of CT images of peritoneal and/or liver metastases from colorectal cancer | Other | Patients with Colo-rectal Cancer |
Primary outcome
Comparison of peritoneal lesion mapping between spectral scanning and conventional scanning
Time frame: Year : 1
Comparison of peritoneal lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).
Comparison of hepatic lesion mapping between spectral scanning and conventional scanning
Time frame: Year : 1
Comparison of hepatic lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).
2 secondary outcomes
Evaluation of response to chemotherapy in RECIST 1.1
Time frame: Year : 1
Evaluation of response to chemotherapy in Radiomics
Time frame: Year : 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- 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.
Rémi GRANGE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Colo-rectal Cancer, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 inclusion and 3 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 20 Sep 2024. 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 Rémi GRANGE, MD ((0)477828963 ext. +33, remi.grange@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of peritoneal lesion mapping between spectral scanning and conventional scanning (time frame: Year : 1). The study lists 2 primary outcomes in all. 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 20 Sep 2024.