Preoperative staging by combidex MRI in patients with resectable esophageal carcinoma
- Conditions
- esophageal canceresophageal carcinoma10017998
- Registration Number
- NL-OMON43056
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
* Patients with histologically proven primary esophageal adenocarcinoma or squamous cell carcinoma, who are planned to undergo a esophagectomy after nCRT
* Patients with suspected lymph nodes metastases on EUS or CT before nCRT
* Age > 18 years
* Providing informed consent
* Unable to provide informed consent
* Known pregnancy or breastfeeding
* Contra-indications for MRI
- Epilepsy
- Metal implants that are not compatible with MRI
* Contra-indications for USPIO based contrast agents
- Prior allergic reaction to ferumoxtran-10 or any other iron preparation
- Prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
- Prior allergic reaction to contrast media of any type
- Hereditary hemochromatosis, thalassemia, sickle cell anemia
- Inflammatory diseases of the abdomen
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Evaluation of the feasibility and diagnostic accuracy of nano-MRI in detecting<br /><br>locoregional lymph nodes metastases after nCRT prior to surgery</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Identify the quantitative and qualitative effect of controlled mechanical<br /><br>ventilation motion compared with *breathhold* in detection of lymph node<br /><br>metastases with nano-MRI after nCRT.<br /><br><br /><br>- Diagnostic accuracy of the nano-MRI in detecting metastases in locoregional<br /><br>lymph nodes in the surgical specimen, ex-vivo after nCRT.<br /><br><br /><br>- Diagnostic accuracy of nano-MRI for staging primary esophageal cancer (CT,<br /><br>PET, EUS). </p><br>