Clinical trial NCT03347630: Pre-operative MRI of Esophagus Cancer
Official title: Prospective Evaluation of MRI in Pre-operative Staging of Esophagus Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagus Cancer
Diagnoses Disease
Keywords: MRI
oesophagus cancer
Staging
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Any pathologically proven oesophagus cancer

Exclusion Criteria:

* MRI contraindication
* Pregnant women
* cervical esophagus cancer

Primary outcomes:
measure: diagnostic performance for staging
timeFrame: 18 months
Secondary outcomes:
measure: Diagnostic performance for staging
timeFrame: 18 months
measure: Prognostic biomarker
timeFrame: 18 months
measure: Diagnostic performance to assess tumor response
timeFrame: 18 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: CHUV
name: Clarisse Dromain, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: