Esophagus CancerSTIRMCONCT03347630
Pre-operative MRI of Esophagus Cancer
A study testing MRI in people with Esophagus Cancer and Diagnoses Disease, run by Dromain Clarisse at 1 site in Switzerland.
Trial summary
The role of MRI in the management of esophageal cancer remains unclear and poorly studied. Recent technical advances suggest that MRI may become a powerful technique for the initial assessment of esophageal cancer, but also for the evaluation of response to neo-adjuvant treatment before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Diagnoses Disease
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Oct 2017to 30 Mar 2019
- Phase
- Interventional
- 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
Who may be able to join
- Any pathologically proven oesophagus cancer
Who cannot join
- MRI contraindication
- Pregnant women
- cervical esophagus cancer
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1011
Clarisse Dromain, MD, phD, 0213147655 ext. 41, clarisse.dromain@chuv.ch
Aurelie Mello, Pr, 0213143293, aurelie.mello@chuv.ch
About this study
Official title: Prospective Evaluation of MRI in Pre-operative Staging of Esophagus Cancers
The role of MRI in the management of esophageal cancer remains unclear and poorly studied. Recent technical advances suggest that MRI may become a powerful technique for the initial assessment of esophageal cancer, but also for the evaluation of response to neo-adjuvant treatment before surgery.
This imaging study will be performed prospectively and consecutively in 60 patients included over a 18-month period in patients wîth newly diagnosed esophageal cancer.
Read more
The aim of this study is to assess the accuracy of MRI to visualize esophageal tumors, to assess tumor burden and potential contact with adjacent structures as well as associated lymph nodes. If chemotherapy or radio-chemotherapy treatment is indicated before surgery, we will also evaluate whether MRI helps us to better evaluate the response to this treatment in comparison to PET-scan or echo. endoscopy which are the examinations currently performed to evaluate the effectiveness of these treatments.
The images of the MRI exams will be interpreted by 1 expert radiologist with no knowledge of the other imaging modalities and transmitted to the doctors in charge for possible consideration for the treatment.
Patients will then be followed for one year according to clinical management standards to study the data on treatment complications and cancer progression at one year.
The main risk is the administration of a gadolinium chelate-based MRI contrast product used routinely. There is also a risk that the results of the MRI may influence the treatment initially planned for example by canceling a surgical procedure.
Read the detailed description
The study will be proppsed consecutively to all patients with a histologically proven diagnosis of esophageal cancer.
An MRI examination including morphological sequences (without and with injection of a gadolinium chelate) functional and dynamic will be carried out in all the patients for initial staging in addition to other diagnostic procedure performed in clinical routine in this indication that are the endo-ultrasonography, CT and PET scanner.
In patients for whom neo-adjuvant treatment with chemotherapy or radio-chemotherapy will be decided and started, a second MRI will be performed 4 to 6 weeks after the end of the neo-adjuvant treatment.
The images of the MR exams will be interpreted by 1 expert radiologist blinded from data of other imaging modalities and transmitted to the doctors in charge of the patient for possible consideration for the treatment.
Patients will then be followed for one year according to regular recommandation to assess mortality / morbidity and PFS at 1 year.
- Conditions
- Esophagus Cancer, Diagnoses Disease
- Being tested
- MRI
- Keywords
- MRI, oesophagus cancer, Staging
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Thoraco-abominal MRI
| Study group | Role | What they receive |
|---|---|---|
| oesophagus cancer MRI | Other | Diagnostic test Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance for staging
TNM staging
Measured: 18 months
Secondary outcomes (3)
Diagnostic performance for staging
Assessment of rate of Under and overstaging
Measured: 18 months
Prognostic biomarker
correlation of MRI data with PFS, morbidity mortality rate and surgical resection
Measured: 18 months
Diagnostic performance to assess tumor response
Correlation of changes of ADC values and histological TRG
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start2 Oct 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dromain Clarisse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dromain Clarisse, University of Lausanne Hospitals
- Investigators
- Clarisse Dromain, MD, phD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347630
- Sponsor's protocol ID
- CER-VD 2017-00388
- Other IDs
- 17_015
- Acronym
- STIRMCO
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of MRI in Pre-operative Staging of Esophagus Cancers
- ClinicalTrials.gov ID
- NCT03347630
- Acronym / sponsor ID
- STIRMCO / CER-VD 2017-00388
- Conditions
- Esophagus Cancer, Diagnoses Disease
- Keywords
- MRI, oesophagus cancer, Staging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dromain ClarisseUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 20 Nov 2017 (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.
The role of MRI in the management of esophageal cancer remains unclear and poorly studied. Recent technical advances suggest that MRI may become a powerful technique for the initial assessment of esophageal cancer, but also for the evaluation of response to neo-adjuvant treatment before surgery.
This imaging study will be performed prospectively and consecutively in 60 patients included over a 18-month period in patients wîth newly diagnosed esophageal cancer.
The aim of this study is to assess the accuracy of MRI to visualize esophageal tumors, to assess tumor burden and potential contact with adjacent structures as well as associated lymph nodes. If chemotherapy or radio-chemotherapy treatment is indicated before surgery, we will also evaluate whether MRI helps us to better evaluate the response to this treatment in comparison to PET-scan or echo. endoscopy which are the examinations currently performed to evaluate the effectiveness of these treatments.
The images of the MRI exams will be interpreted by 1 expert radiologist with no knowledge of the other imaging modalities and transmitted to the doctors in charge for possible consideration for the treatment.
Patients will then be followed for one year according to clinical management standards to study the data on treatment complications and cancer progression at one year.
The main risk is the administration of a gadolinium chelate-based MRI contrast product used routinely. There is also a risk that the results of the MRI may influence the treatment initially planned for example by canceling a surgical procedure.
Detailed description
The study will be proppsed consecutively to all patients with a histologically proven diagnosis of esophageal cancer.
An MRI examination including morphological sequences (without and with injection of a gadolinium chelate) functional and dynamic will be carried out in all the patients for initial staging in addition to other diagnostic procedure performed in clinical routine in this indication that are the endo-ultrasonography, CT and PET scanner.
In patients for whom neo-adjuvant treatment with chemotherapy or radio-chemotherapy will be decided and started, a second MRI will be performed 4 to 6 weeks after the end of the neo-adjuvant treatment.
The images of the MR exams will be interpreted by 1 expert radiologist blinded from data of other imaging modalities and transmitted to the doctors in charge of the patient for possible consideration for the treatment.
Patients will then be followed for one year according to regular recommandation to assess mortality / morbidity and PFS at 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oesophagus cancer MRI | Other | Diagnostic Test: MRIDiagnostic test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any pathologically proven oesophagus cancer
Key exclusion criteria (3 listed)
- MRI contraindication
- Pregnant women
- cervical esophagus cancer
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 |
|---|---|---|
| MRIThoraco-abominal MRI | Diagnostic test | oesophagus cancer MRI |
Primary outcome
diagnostic performance for staging
Time frame: 18 months
TNM staging
3 secondary outcomes
Diagnostic performance for staging
Time frame: 18 months
Prognostic biomarker
Time frame: 18 months
Diagnostic performance to assess tumor response
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- 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.
Clarisse Dromain, MD, phD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Esophagus Cancer and Diagnoses Disease, run by Dromain Clarisse at 1 site in Switzerland.
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 1 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 21 Nov 2017. 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 Switzerland. 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 Clarisse Dromain, MD, PhD (0795568369 ext. 41, clarisse.dromain@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance for staging (time frame: 18 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 21 Nov 2017.