The Application of 3T MRI in Esophageal Cancer

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03635619
Collaborator
(none)
400
1
63.9
6.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
400 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
3 T MRI in the Preoperative TN Staging and Prediction of Response to Neoadjuvant Therapy in Patients With Esophageal Cancer
Actual Study Start Date :
Sep 2, 2018
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Outcome Measures

Primary Outcome Measures

  1. MRI TN staging in Esophageal Cancer [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

Secondary Outcome Measures

  1. MRI prediction of prognosis in esophageal cancer [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan Cancer Hospital Zhengzhou China

Sponsors and Collaborators

  • Henan Cancer Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Henan Cancer Hospital
ClinicalTrials.gov Identifier:
NCT03635619
Other Study ID Numbers:
  • FSK001
First Posted:
Aug 17, 2018
Last Update Posted:
Apr 1, 2020
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Henan Cancer Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2020