Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-10-02
2019-03-30
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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oesophagus cancer MRI
Diagnostic test
MRI
Thoraco-abominal MRI
Interventions
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MRI
Thoraco-abominal MRI
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women
* cervical esophagus cancer
18 Years
ALL
No
Sponsors
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Dromain Clarisse
OTHER
Responsible Party
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Dromain Clarisse
MD, phD
Principal Investigators
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Clarisse Dromain, MD, phD
Role: PRINCIPAL_INVESTIGATOR
CHUV
Locations
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CHUV
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Clarisse Dromain, MD, phD
Role: primary
Aurelie Mello, Pr
Role: backup
Other Identifiers
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17_015
Identifier Type: OTHER
Identifier Source: secondary_id
CER-VD 2017-00388
Identifier Type: -
Identifier Source: org_study_id