Pre-operative MRI of Esophagus Cancer

Diagnoses Disease Clinical Trial

— STIRMCO  

Official title:

Prospective Evaluation of MRI in Pre-operative Staging of Esophagus Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03347630
• Other study ID #: CER-VD 2017-00388
• Secondary ID: 17_015
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2017
• Last updated: November 20, 2017
• Start date: October 2, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: November 2017
• Source: University of Lausanne Hospitals
• Contact: Clarisse Dromain, MD, PhD
• Phone: 0795568369
• Email: clarisse.dromain[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any pathologically proven oesophagus cancer

Exclusion Criteria:

• MRI contraindication

• Pregnant women

• cervical esophagus cancer

Related Conditions & MeSH terms

• Diagnoses Disease
• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Diagnostic Test:
• MRI
Thoraco-abominal MRI

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Dromain Clarisse

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic performance for staging	TNM staging	18 months
Secondary	Diagnostic performance for staging	Assessment of rate of Under and overstaging	18 months
Secondary	Prognostic biomarker	correlation of MRI data with PFS, morbidity mortality rate and surgical resection	18 months
Secondary	Diagnostic performance to assess tumor response	Correlation of changes of ADC values and histological TRG	18 months