Pre-operative MRI of Esophagus Cancer (STIRMCO)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Diagnoses Disease; Esophagus Cancer
• Intervention / Treatment: Diagnostic test: MRI

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clarisse Dromain, MD, PhD; Phone Number: 41 0795568369; Email: clarisse.dromain@chuv.ch
• Study Contact Backup: Name: Markus Schafer, Pr; Phone Number: 41 0795561699; Email: markus.schafer@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • CHUV
      • Contact: Clarisse Dromain, MD, phD; Phone Number: 41 0213147655; Email: clarisse.dromain@chuv.ch
      • Contact: Aurelie Mello, Pr; Phone Number: 0213143293; Email: aurelie.mello@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any pathologically proven oesophagus cancer

Exclusion Criteria:

• MRI contraindication
• Pregnant women
• cervical esophagus cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: oesophagus cancer MRI; Diagnostic test	Diagnostic test: MRI; Thoraco-abominal MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic performance for staging	TNM staging	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance for staging	Assessment of rate of Under and overstaging	18 months
Prognostic biomarker	correlation of MRI data with PFS, morbidity mortality rate and surgical resection	18 months
Diagnostic performance to assess tumor response	Correlation of changes of ADC values and histological TRG	18 months

Collaborators and Investigators

• Sponsor: Dromain Clarisse
• Investigators: Principal Investigator: Clarisse Dromain, MD, phD, CHUV

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2017
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): March 30, 2019

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (ACTUAL): November 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: MRI; Staging; oesophagus cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: CER-VD 2017-00388; 17_015 (OTHER: CRC CHUV)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No