sing MRI to predict the success of anticancer treatment before surgery to the esophagus (gullet) and the gastroesophageal junction (gullet-stomach junction)

Not Applicable

• Conditions: Esophageal cancer and cancer in the gastroesophageal junction.; Cancer; Esophagus cancer, gastro-esophageal junction cancer

• Registration Number: ISRCTN35827514
• Lead Sponsor: ppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-22
• Last Update Posted: 15 March 2021
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged over 18 years
2. Esophageal cancer or gastroesophageal junctional cancer Siewert I and II
3. Planned for neoadjuvant treatment and surgery
4. Clinical stage T1-4aN0-3M0

Exclusion Criteria

1. Cannot undergo MRI due to claustrophobia
2. Implants contraindicating MRI fitted, including pacemaker, pacemaker electrodes, mechanical heart valve, CNS electrodes and cochlear implants
3. Language difficulties making informed consent impossible
4. Renal failure
5. Allergy to contrast medium
6. Pregnancy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main outcome measure is specificity and sensitivity for prediction of complete pathological response to neoadjuvant treatment. The radiomic results will be calculated by an operated blinded for other clinical data and the score will be entered into a dataset. Other radiologic markers (SUV-max etc) will be entered as well. The pathological examination will also be entered into a blinded dataset and correlation analyses will be performed.

Secondary Outcome Measures

Name	Time	Method
Tumor immune cell population composition in relation to pathological clinical response. Plasma and tumor samples before and after neoadjuvant therapy are frozen and saved for future analysis. In circulating plasma, biomarker assays will be preformed before, during and after neoadjuvant treatment along with appropriate bioinformatic statistical interpretation (Oling, Immunooncology panel). In addition to this, immunohistochemical analyses of tumour material (CD4, FoxP3, CD8/CD45RO andEn CD20), analyses for immunology gene-expression before and after neoadjuvant treatment (Nanostring, nCounter Immunology ans Inflammation panels) will be performed.