FDG-PET/MRI for re-staging of esophageal cancer: a feasibility study
Not yet recruiting
- Conditions
- carcinoma of the oesophagusoesophageal cancer10017990
Recruitment & Eligibility
- Status
- Pending
- 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 as part of standard clinical care.
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-nonavid 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 <p>The primary study parameter is qualitative re-staging after nCRT based on<br /><br>FDG-PET/MRI versus FDG-PET/CT, with pathology as gold standard (i.e.<br /><br>histopathologic assessment of the resection specimen when patients undergo<br /><br>surgery after nCRT, or histopathology/cytopathology of the primary tumor and<br /><br>suspected (distant) metastases as obtained during standard follow-up when<br /><br>patients do not undergo surgery or postpone surgery after nCRT).The other<br /><br>primary study parameters to assess feasibility include: experienced burden of<br /><br>undergoing FDG-PET/MRI, measurements of the primary tumor and lymph nodes,<br /><br>quantitative measurements of standardized uptake values at the primary tumor<br /><br>and suspected locoregional lymph nodes on FDG-PET/MRI compared to FDG-PET/CT,<br /><br>and quantitative measurements of the apparent diffusion coefficient at the<br /><br>primary tumor and suspected locoregional lymph nodes on FDG-PET/MRI.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable, since the study has one primary objective.</p><br>