Pet ReInforced by MRI Enhancing detection of Residual Oesophageal cancer
Recruiting
- Conditions
- ocally advanced esophageal adenocarcinoma or squamous cell carcinoma
- Registration Number
- NL-OMON28571
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Age =18 years;
- Histologically proven esophageal adenocarcinoma or squamous cell carcinoma located caudally to the carina;
- Completed neoadjuvant chemoradiotherapy (nCRT);
- Scheduled to undergo FDG-PET/CT at 4-6 weeks after nCRT or at 8-12 weeks after nCRT.
Exclusion Criteria
- Contra-indications for MRI (e.g. pacemaker, metal implant, claustrophobia);
- Contra-indications for iodinated contrast media (e.g. previous contrast-allergy or eGFR <30 ml/min/1,73m2);
- FDG-non avid tumor as determined from the pre-treatment PET/CT scan;
- Incapacitated patients, prohibiting the understanding and giving of informed consent and to complete the questionnaire on experienced burden with PET/MRI.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study parameter is qualitative re-staging after nCRT based on FDG-PET/MRI versus FDG-PET/CT, with pathology as gold standard (i.e. histopathologic assessment of the resection specimen when patients undergo surgery after nCRT, or histopathology/cytopathology of the primary tumor and suspected (distant) metastases as obtained during standard follow-up when patients do not undergo surgery or postpone surgery after nCRT).
- Secondary Outcome Measures
Name Time Method Experienced burden of undergoing FDG-PET/MRI; quantitative measurements of the primary tumor and lymph nodes.