Pre-operative MRI of Esophagus Cancer (STIRMCO)
Primary Purpose
Esophagus Cancer, Diagnoses Disease
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Esophagus Cancer focused on measuring MRI, oesophagus cancer, Staging
Eligibility Criteria
Inclusion Criteria:
- Any pathologically proven oesophagus cancer
Exclusion Criteria:
- MRI contraindication
- Pregnant women
- cervical esophagus cancer
Sites / Locations
- CHUVRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
oesophagus cancer MRI
Arm Description
Diagnostic test
Outcomes
Primary Outcome Measures
diagnostic performance for staging
TNM staging
Secondary Outcome Measures
Diagnostic performance for staging
Assessment of rate of Under and overstaging
Prognostic biomarker
correlation of MRI data with PFS, morbidity mortality rate and surgical resection
Diagnostic performance to assess tumor response
Correlation of changes of ADC values and histological TRG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03347630
Brief Title
Pre-operative MRI of Esophagus Cancer
Acronym
STIRMCO
Official Title
Prospective Evaluation of MRI in Pre-operative Staging of Esophagus Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
March 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dromain Clarisse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Diagnoses Disease
Keywords
MRI, oesophagus cancer, Staging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
oesophagus cancer MRI
Arm Type
Other
Arm Description
Diagnostic test
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Thoraco-abominal MRI
Primary Outcome Measure Information:
Title
diagnostic performance for staging
Description
TNM staging
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Diagnostic performance for staging
Description
Assessment of rate of Under and overstaging
Time Frame
18 months
Title
Prognostic biomarker
Description
correlation of MRI data with PFS, morbidity mortality rate and surgical resection
Time Frame
18 months
Title
Diagnostic performance to assess tumor response
Description
Correlation of changes of ADC values and histological TRG
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any pathologically proven oesophagus cancer
Exclusion Criteria:
MRI contraindication
Pregnant women
cervical esophagus cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarisse Dromain, MD, PhD
Phone
0795568369
Ext
41
Email
clarisse.dromain@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Schafer, Pr
Phone
0795561699
Ext
41
Email
markus.schafer@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarisse Dromain, MD, phD
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clarisse Dromain, MD, phD
Phone
0213147655
Ext
41
Email
clarisse.dromain@chuv.ch
First Name & Middle Initial & Last Name & Degree
Aurelie Mello, Pr
Phone
0213143293
Email
aurelie.mello@chuv.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Pre-operative MRI of Esophagus Cancer
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