Clinical trial NCT03635619: The Application of 3T MRI in Esophageal Cancer
Official title: 3 T MRI in the Preoperative TN Staging and Prediction of Response to Neoadjuvant Therapy in Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer TNM Staging
Magnetic Resonance Imaging
Prognosis
Keywords: Esophageal Cancer
Magnetic Resonance Imaging
Prognosis
neoplasm staging
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2018-08-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects with endoscopically biopsy-proven EC will receive treatment.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MRI TN staging in Esophageal Cancer
timeFrame: Sep 1, 2018-Dec 31, 2019
Secondary outcomes:
measure: MRI prediction of prognosis in esophageal cancer
timeFrame: Sep 1, 2018-Dec 31, 2020
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Henan Cancer Hospital
name: Baoxia He, MD
role: STUDY_DIRECTOR
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