Pre-operative MRI of Esophagus Cancer (STIRMCO)

• ClinicalTrials.gov Identifier: NCT03347630
• Recruitment Status: Unknown
• First Posted: November 20, 2017
• Last Update Posted: November 21, 2017
• Sponsor: Dromain Clarisse
• Information provided by (Responsible Party): Dromain Clarisse, University of Lausanne Hospitals

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.

Condition or disease	Intervention/treatment	Phase
Esophagus Cancer; Diagnoses Disease	Diagnostic Test: MRI	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prospective Evaluation of MRI in Pre-operative Staging of Esophagus Cancers
• Actual Study Start Date: October 2, 2017
• Estimated Primary Completion Date: October 1, 2018
• Estimated Study Completion Date: March 30, 2019

Arms and Interventions

Arm	Intervention/treatment
oesophagus cancer MRI; Diagnostic test	Diagnostic Test: MRI; Thoraco-abominal MRI

Outcome Measures

Primary Outcome Measures :

1. diagnostic performance for staging [ Time Frame: 18 months ]
   TNM staging

Secondary Outcome Measures :

1. Diagnostic performance for staging [ Time Frame: 18 months ]
   Assessment of rate of Under and overstaging
2. Prognostic biomarker [ Time Frame: 18 months ]
   correlation of MRI data with PFS, morbidity mortality rate and surgical resection
3. Diagnostic performance to assess tumor response [ Time Frame: 18 months ]
   Correlation of changes of ADC values and histological TRG

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Any pathologically proven oesophagus cancer

Exclusion Criteria:

• MRI contraindication
• Pregnant women
• cervical esophagus cancer

Contacts and Locations

Contacts

Contact: Clarisse Dromain, MD, PhD; 0795568369 ext 41; clarisse.dromain@chuv.ch

Contact: Markus Schafer, Pr; 0795561699 ext 41; markus.schafer@chuv.ch

Locations

Switzerland

CHUV; Recruiting

Lausanne, Vaud, Switzerland, 1011

Contact: Clarisse Dromain, MD, phD 0213147655 ext 41 clarisse.dromain@chuv.ch

Contact: Aurelie Mello, Pr 0213143293 aurelie.mello@chuv.ch

Sponsors and Collaborators

Dromain Clarisse

Investigators

• Principal Investigator: Clarisse Dromain, MD, phD; CHUV

More Information

• Responsible Party: Dromain Clarisse, MD, phD, University of Lausanne Hospitals
• ClinicalTrials.gov Identifier: NCT03347630
• Other Study ID Numbers: CER-VD 2017-00388; 17_015 ( Other Identifier: CRC CHUV )
• First Posted: November 20, 2017
• Last Update Posted: November 21, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dromain Clarisse, University of Lausanne Hospitals:

MRI; oesophagus cancer; Staging

Additional relevant MeSH terms:

Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases