The Application of 3T MRI in Esophageal Cancer

March 31, 2020 updated by: Henan Cancer Hospital

3 T MRI in the Preoperative TN Staging and Prediction of Response to Neoadjuvant Therapy in Patients With Esophageal Cancer

It is very significant that assessing TN staging in esophageal cancer patients before surgery, furthermore, determining the optimize surgical strategy, predict the the efficacy of radiotherapy for patients who were not chosen to be surgeried, and define the range of lymph node for radiotherapy. It has been reported that the application of MRI in metastasis of lymph node of other cancer, but not in metastasis lymph node with esophageal cancer. Only a few studies focused on T staging using conventional MRI in esophageal cancer, however, relatively new sequences in the chest deserve widely used. To develop a pre-treatment evaluation methods for TN staging in patient with esophageal cancer by utilization of the new imaging methods (T2-TSE-BLADE, T2 maps, StarVIBE). By analysising the relationship between TN staging and imaging features to find the imaging characteristics for TN staging, and to find the indicators of magnetic resonance imaging new technology and reference values for facilitate pre-treatment diagnosis of lymphnode metastasis, optimize surgical strategy, predict the the efficacy of adjunctive therapy, and OS and define the range of lymph node for radiotherapy, as making personal treatment planning for esophageal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To explore the value of 3 T MRI using multiple sequences, including T2-TSE-BLADE, T2 maps and StarVIBE, in evaluating the preoperative TN staging and prediction of response to neoadjuvant therapy and OS in patients with esophageal cancer.

Patients with endoscopically biopsy-proven EC were prospectively enrolled for imaging on a 3 T scanner. The MRI protocol included T2-TSE-BLADE, T2 maps and StarVIBE sequences, and so on. Patients received treatment according to NCCN guideline. Readers assigned a TN stage on MRI, and post-operative pathologic confirmation was considered the gold standard. Inter-reader agreement, the diagnostic accuracy of TN staging on MRI were analyzed and compared to post-operative pathologic TN staging. MRI features were analyzed to find the correlation between pretreatment MRI features and response or OS. The study will includ 400 patients. Inter-reader agreements of TN staging were analyzed excellent for MRI. Diagnostic accuracy of MRI will be calculated.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinrong Qu
  • Phone Number: 0371-65587595
  • Email: qjryq@126.com

Study Locations

  • China
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

subjects with endoscopically biopsy-proven EC will receive treatment.

Description

Inclusion Criteria:

  1. Consecutive patients with preoperative pathologically con-firmed EC by endoscopy and preoperative imaging data (esophagography\CT\EUS\MRI) were included.
  2. No contraindications for MRI examination.
  3. The patients participate in this study with informed consent.

Exclusion Criteria:

  1. The patients couldn't performed MR scanning or artefacts affect the evaluation.
  2. ThePatients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
  3. PatientsThe patients refuse to participate in the project.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI TN staging in Esophageal Cancer
Time Frame: Sep 1, 2018-Dec 31, 2019
To explore the value of 3 T MRI using multiple sequences in evaluating the preoperative TN staging of esophageal cancer treated with surgery, with pathologic confirmation
Sep 1, 2018-Dec 31, 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI prediction of prognosis in esophageal cancer
Time Frame: Sep 1, 2018-Dec 31, 2020
To explore the value of 3 T MRI using multiple sequences in predicting the response and OS of esophageal cancer treated with surgery.
Sep 1, 2018-Dec 31, 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Study Director: Baoxia He, MD, Henan Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2018

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSK001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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