NCT03635619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

September 2, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 1, 2020

Status Verified

August 1, 2019

Enrollment Period

5.3 years

First QC Date

August 15, 2018

Last Update Submit

March 31, 2020

Conditions

Esophageal Cancer TNM StagingMagnetic Resonance ImagingPrognosis

Keywords

Esophageal CancerMagnetic Resonance ImagingPrognosisneoplasm staging

Outcome Measures

Primary Outcomes (1)

  • MRI TN staging in Esophageal Cancer

    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 Outcomes (1)

  • MRI prediction of prognosis in esophageal cancer

    Sep 1, 2018-Dec 31, 2020

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects with endoscopically biopsy-proven EC will receive treatment.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

Related Publications (9)

  • Dumont P, Wihlm JM, Hentz JG, Roeslin N, Lion R, Morand G. Respiratory complications after surgical treatment of esophageal cancer. A study of 309 patients according to the type of resection. Eur J Cardiothorac Surg. 1995;9(10):539-43. doi: 10.1016/s1010-7940(05)80001-6.

    PMID: 8562096BACKGROUND

  • Wu CC, Chen CJ. Esophageal carcinoma. N Engl J Med. 2015 Apr 9;372(15):1472. doi: 10.1056/NEJMc1500692. No abstract available.

    PMID: 25853761BACKGROUND

  • Omloo JM, Lagarde SM, Hulscher JB, Reitsma JB, Fockens P, van Dekken H, Ten Kate FJ, Obertop H, Tilanus HW, van Lanschot JJ. Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the mid/distal esophagus: five-year survival of a randomized clinical trial. Ann Surg. 2007 Dec;246(6):992-1000; discussion 1000-1. doi: 10.1097/SLA.0b013e31815c4037.

    PMID: 18043101BACKGROUND

  • Allum WH, Blazeby JM, Griffin SM, Cunningham D, Jankowski JA, Wong R; Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, the British Society of Gastroenterology and the British Association of Surgical Oncology. Guidelines for the management of oesophageal and gastric cancer. Gut. 2011 Nov;60(11):1449-72. doi: 10.1136/gut.2010.228254. Epub 2011 Jun 24. No abstract available.

    PMID: 21705456BACKGROUND

  • Chen J, Chen C, Xia C, Huang Z, Zuo P, Stemmer A, Song B. Quantitative free-breathing dynamic contrast-enhanced MRI in hepatocellular carcinoma using gadoxetic acid: correlations with Ki67 proliferation status, histological grades, and microvascular density. Abdom Radiol (NY). 2018 Jun;43(6):1393-1403. doi: 10.1007/s00261-017-1320-3.

    PMID: 28939963BACKGROUND

  • Cassinotto C, Feldis M, Vergniol J, Mouries A, Cochet H, Lapuyade B, Hocquelet A, Juanola E, Foucher J, Laurent F, De Ledinghen V. MR relaxometry in chronic liver diseases: Comparison of T1 mapping, T2 mapping, and diffusion-weighted imaging for assessing cirrhosis diagnosis and severity. Eur J Radiol. 2015 Aug;84(8):1459-1465. doi: 10.1016/j.ejrad.2015.05.019. Epub 2015 May 19.

    PMID: 26032126BACKGROUND

  • Zhang H, Xue H, Alto S, Hui L, Kannengiesser S, Berthold K, Jin Z. Integrated Shimming Improves Lesion Detection in Whole-Body Diffusion-Weighted Examinations of Patients With Plasma Disorder at 3 T. Invest Radiol. 2016 May;51(5):297-305. doi: 10.1097/RLI.0000000000000238.

    PMID: 26704452BACKGROUND

  • Li X, Qu JR, Luo JP, Li J, Zhang HK, Shao NN, Kwok K, Zhang SN, Li YL, Liu CC, Zee CS, Li HL. Effect of intravenous gadolinium-DTPA on diffusion-weighted imaging of brain tumors: a short temporal interval assessment. J Magn Reson Imaging. 2014 Sep;40(3):616-21. doi: 10.1002/jmri.24386. Epub 2013 Oct 31.

    PMID: 24925118BACKGROUND

  • Zhang F, Qu J, Zhang H, Liu H, Qin J, Ding Z, Li Y, Ma J, Zhang Z, Wang Z, Zhang J, Zhang S, Dong Y, Grimm R, Kamel IR, Li H. Preoperative T Staging of Potentially Resectable Esophageal Cancer: A Comparison between Free-Breathing Radial VIBE and Breath-Hold Cartesian VIBE, with Histopathological Correlation. Transl Oncol. 2017 Jun;10(3):324-331. doi: 10.1016/j.tranon.2017.02.006. Epub 2017 Mar 19.

    PMID: 28327459BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Baoxia He, MD

    Henan Cancer Hospital

    STUDY DIRECTOR

Central Study Contacts

Jinrong Qu

CONTACT

0371-65587595qjryq@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

September 2, 2018

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

April 1, 2020

Record last verified: 2019-08

Locations

CN(1)