The Application of 3T MRI in Esophageal Cancer

Magnetic Resonance Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03635619
• Other study ID #: FSK001
• Status: Recruiting
• Start date: September 2, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2019
• Source: Henan Cancer Hospital
• Contact: Jinrong Qu
• Phone: 0371-65587595
• Email: qjryq[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer TNM Staging
• Esophageal Neoplasms
• Magnetic Resonance Imaging
• Prognosis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wu CC, Chen CJ. Esophageal carcinoma. N Engl J Med. 2015 Apr 9;372(15):1472. doi: 10.1056/NEJMc1500692. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MRI prediction of prognosis in esophageal cancer	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