Pre-operative MRI of Esophagus Cancer

NCT03347630 | Unknown DMC

• 2 other identifiers: CER-VD 2017-0038817_015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Cancer; Diagnoses Disease

Keywords

MRI; oesophagus cancer; Staging

Outcome Measures

Primary Outcomes (1)

• diagnostic performance for staging

  TNM staging

  18 months

Secondary Outcomes (3)

• Diagnostic performance for staging

  18 months

• Prognostic biomarker

  18 months

• Diagnostic performance to assess tumor response

  18 months

Study Arms (1)

oesophagus cancer MRI

OTHER

Diagnostic test

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Thoraco-abominal MRI

oesophagus cancer MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any pathologically proven oesophagus cancer

You may not qualify if:

• MRI contraindication
• Pregnant women
• cervical esophagus cancer

Sponsors & Collaborators

• Dromain Clarisse: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Clarisse Dromain, MD, phD

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clarisse Dromain, MD, PhD

CONTACT

0795568369; clarisse.dromain@chuv.ch

Markus Schafer, Pr

CONTACT

0795561699; markus.schafer@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, phD

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: October 2, 2017
• Primary Completion: October 1, 2018
• Study Completion: March 30, 2019
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)