Colorectal Cancer With Liver MetastasesMetaIRMNCT06552117
ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer ( MetaIRM)
A study testing an elastoMRI sequence in people with Colorectal Cancer With Liver Metastases, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Currently, the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimen.The histological data make it possible to define categories (responder, partial responder, non-responder). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer With Liver Metastases
- What is being tested?
- an elastoMRI sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 30 Jun 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
- Adult patients ≥18 years old, followed for colorectal cancer with hepatic metastases.
- The diagnosis of metastasis can be made: either by tumor biopsy or by the appearance during follow-up of colorectal cancer of at least one liver lesion with the characteristics of metastasis (fibrous tumor type imaging)
- Patient with an indication to receive first-line chemotherapy for liver metastases, whether or not associated with targeted therapy
- Patient with at least one hepatic metastasis greater than 2cm
Who cannot join
- Patients not affiliated with social security
- Pregnant or breastfeeding women
- Patients under guardianship, curatorship or safeguard of justice
- Patients with a contraindication to MRI or to the injection of contrast agent in MRI. The classic contraindications for MRI are defined by the French Society of Radiology:http://www.sfrnet.org/sfr/professionnels/1-fiche-information-patients/irm/index.phtml
- Lack of signed patient consent
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
Official title: ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer
Currently, the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimen.The histological data make it possible to define categories (responder, partial responder, non-responder).
Overall survival (OS: overall survival) after surgery crucially depends on the response to neoadjuvant chemotherapy. Current criteria for predicting histological response in preoperative imaging are not satisfactory.
Read more
The working hypothesis is that it is possible to better differentiate the tissue response to conventional chemotherapies and anti-angiogenics through MRI elastography by quantifying the changes in tissue mechanical properties induced by systemic treatments.
The objectives is to evaluate the mechanical properties obtained by elasto MRI according to the systemic treatments envisaged: conventional chemotherapy such as Folfox or combined with targeted therapy
Read the detailed description
Currently, the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimen.The histological data make it possible to define categories (responder, partial responder, non-responder).
Overall survival (OS: overall survival) after surgery crucially depends on the response to neoadjuvant chemotherapy. Current criteria for predicting histological response in preoperative imaging are not satisfactory.
The working hypothesis is that it is possible to better differentiate the tissue response to conventional chemotherapies and anti-angiogenics through MRI elastography by quantifying the changes in tissue mechanical properties induced by systemic treatments.
The objectives is to evaluate the mechanical properties obtained by elasto MRI according to the systemic treatments envisaged: conventional chemotherapy such as Folfox or combined with targeted therapy
This is an open, non-randomized, non-comparative trial with three parallel groups
- 10 patients immediately resectable and receiving preoperative chemotherapy based on Folfox alone.
- 30 potentially resectable patients (borderline) with two groups of patients representing the combinations usual triplets: chemotherapy and targeted therapy: Folfox+bevacizumab (15 patients) and Folfox + Cetuximab (15 patients).
- 10 unresectable patients with two groups of patients representing the usual combinations: cytotoxic pure vs cytotoxic + targeted therapy (bevacizumab or Cetuximab).
- Conditions
- Colorectal Cancer With Liver Metastases
- Being tested
- an elastoMRI sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an elastoMRI sequenceOther
Addition of an MRI elasto sequence performed during MRI performed as part of the treatment
| Study group | Role | What they receive |
|---|---|---|
| immediately resectable patients. | Other | 10 immediately resectable patients receiving preoperative chemotherapy based on Folfox alone. Receives: Other: an elastoMRI sequence |
| potentially resectable patients | Other | 30 potentially resectable patients (borderline) with two groups of patients representing the usual combinations of triplets: chemotherapy and targeted therapy: Folfox + bevacizumab (15 patients) and Folfox + Cetuximab (15 patients). Receives: Other: an elastoMRI sequence |
| unresectable patients | Other | 10 unresectable patients with two groups of patients representing the usual combinations: pure cytotoxics vs cytotoxics + targeted therapy ( bevacizumab or Cetuximab). Receives: Other: an elastoMRI sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
The Primary endpoint is variation in the measurement of the elasticity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response criteria RECIST1.1
Measured: 6 months
Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
The Primary endpoint is variation in the measurement of the elasticity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response Chun criteria
Measured: 6 months
Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
The Primary endpoint is variation in the measurement of the viscosity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response criteria RECIST1.1
Measured: 6 months
Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
The Primary endpoint is variation in the measurement of the viscosity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response Chun criteria
Measured: 6 months
Secondary outcomes (4)
Correlate in operated patients the mechanical properties obtained by elastomeric MRI with the histological response.
Measurement of the elasticity and viscosity of the metastases by preoperative elastography-MRI according to the histological response classified as complete response, partial response (viable tissue less than 50% of the tumor volume), or non-responder (viable tissue greater than 50% of the tumor volume).
Measured: by preoperative
Compare the metastases detected of liver MRI with liver CT
Number of metastases detected
Measured: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
Compare the type of tumor response of liver MRI with liver CT
type of tumor response using RECIST 1.1
Measured: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
Compare tumour response of liver MRI with liver CT
Chun criteria
Measured: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer With Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gael Goujon, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552117
- Sponsor's protocol ID
- APHP220209
- Acronym
- MetaIRM
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06552117
- Acronym / sponsor ID
- MetaIRM / APHP220209
- Conditions
- Colorectal Cancer With Liver Metastases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Aug 2024 (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.
Currently, the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimen.The histological data make it possible to define categories (responder, partial responder, non-responder).
Overall survival (OS: overall survival) after surgery crucially depends on the response to neoadjuvant chemotherapy. Current criteria for predicting histological response in preoperative imaging are not satisfactory.
The working hypothesis is that it is possible to better differentiate the tissue response to conventional chemotherapies and anti-angiogenics through MRI elastography by quantifying the changes in tissue mechanical properties induced by systemic treatments.
The objectives is to evaluate the mechanical properties obtained by elasto MRI according to the systemic treatments envisaged: conventional chemotherapy such as Folfox or combined with targeted therapy
Detailed description
Currently, the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimen.The histological data make it possible to define categories (responder, partial responder, non-responder).
Overall survival (OS: overall survival) after surgery crucially depends on the response to neoadjuvant chemotherapy. Current criteria for predicting histological response in preoperative imaging are not satisfactory.
The working hypothesis is that it is possible to better differentiate the tissue response to conventional chemotherapies and anti-angiogenics through MRI elastography by quantifying the changes in tissue mechanical properties induced by systemic treatments.
The objectives is to evaluate the mechanical properties obtained by elasto MRI according to the systemic treatments envisaged: conventional chemotherapy such as Folfox or combined with targeted therapy
This is an open, non-randomized, non-comparative trial with three parallel groups
- 10 patients immediately resectable and receiving preoperative chemotherapy based on Folfox alone.
- 30 potentially resectable patients (borderline) with two groups of patients representing the combinations usual triplets: chemotherapy and targeted therapy: Folfox+bevacizumab (15 patients) and Folfox + Cetuximab (15 patients).
- 10 unresectable patients with two groups of patients representing the usual combinations: cytotoxic pure vs cytotoxic + targeted therapy (bevacizumab or Cetuximab).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| immediately resectable patients. | Other | Other: an elastoMRI sequence10 immediately resectable patients receiving preoperative chemotherapy based on Folfox alone. |
| potentially resectable patients | Other | Other: an elastoMRI sequence30 potentially resectable patients (borderline) with two groups of patients representing the usual combinations of triplets: chemotherapy and targeted therapy: Folfox + bevacizumab (15 patients) and Folfox + Cetuximab (15 patients). |
| unresectable patients | Other | Other: an elastoMRI sequence10 unresectable patients with two groups of patients representing the usual combinations: pure cytotoxics vs cytotoxics + targeted therapy ( bevacizumab or Cetuximab). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients ≥18 years old, followed for colorectal cancer with hepatic metastases.
- The diagnosis of metastasis can be made: either by tumor biopsy or by the appearance during follow-up of colorectal cancer of at least one liver lesion with the characteristics of metastasis (fibrous tumor type imaging)
- Patient with an indication to receive first-line chemotherapy for liver metastases, whether or not associated with targeted therapy
- Patient with at least one hepatic metastasis greater than 2cm
Key exclusion criteria (5 listed)
- Patients not affiliated with social security
- Pregnant or breastfeeding women
- Patients under guardianship, curatorship or safeguard of justice
- Patients with a contraindication to MRI or to the injection of contrast agent in MRI. The classic contraindications for MRI are defined by the French Society of Radiology:http://www.sfrnet.org/sfr/professionnels/1-fiche-information-patients/irm/index.phtml
- Lack of signed patient consent
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 |
|---|---|---|
| an elastoMRI sequenceAddition of an MRI elasto sequence performed during MRI performed as part of the treatment | Other | immediately resectable patients., potentially resectable patients, unresectable patients |
Primary outcome
Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
Time frame: 6 months
The Primary endpoint is variation in the measurement of the elasticity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response criteria RECIST1.1
Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
Time frame: 6 months
The Primary endpoint is variation in the measurement of the elasticity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response Chun criteria
Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
Time frame: 6 months
The Primary endpoint is variation in the measurement of the viscosity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response criteria RECIST1.1
Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
Time frame: 6 months
The Primary endpoint is variation in the measurement of the viscosity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response Chun criteria
4 secondary outcomes
Correlate in operated patients the mechanical properties obtained by elastomeric MRI with the histological response.
Time frame: by preoperative
Compare the metastases detected of liver MRI with liver CT
Time frame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
Compare the type of tumor response of liver MRI with liver CT
Time frame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
Compare tumour response of liver MRI with liver CT
Time frame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
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 Aug 2024.
- 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.
Gael Goujon principal investigator
APHP
Questions about this trial
What is this clinical trial studying?
A study testing an elastoMRI sequence in people with Colorectal Cancer With Liver Metastases, run by Assistance Publique - Hôpitaux de Paris.
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 5 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 Aug 2024. 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 Valérie VILGRAIN (+33 1 40 87 53 58, valerie.vilgrain@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy (time frame: 6 months). The study lists 4 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 13 Aug 2024.