Preoperative identification of response to neoadjuvant chemoradiotherapy for esophageal cancer.
- Conditions
- Esophageal cancer.MRI. PET-CT.Oesofaguscarcinoom.Slokdarmkanker.
- Registration Number
- NL-OMON24280
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Histologically confirmed carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy);
2. Potentially resectable tumor (cT1b-4a N0-3 M0);
Exclusion Criteria
1. Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the Radiology department of the UMC Utrecht;
2. Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nefropathy according to the UMC Utrecht protocol ‘Preventie contrastreactie en contrast nefropathie, Versie 2 februari 2012’. In patients with risk factors a minimum GFR of 60 mL/min/1.73m2 will be required;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The additional diagnostic value -in terms of accuracy, sensitivity, specificity and predicitve values- of anatomical and functional MRI to PET-CT in the evaluation of treatment response to neoadjuvant chemoradiation therapy for patients with esophageal cancer, as compared to the pathological specimen as gold standard.
- Secondary Outcome Measures
Name Time Method 1. Assessment of the optimal (MRI and PET-CT) imaging parameters that correlate best with pathological response;<br /><br>2. Assessment of the optimal timing for the imaging series;<br /><br>3. Assessment of the diagnostic value of MRI for post-nCRT restaging of T- and N-stage as compared to histopathology;<br /><br>4. Assessment of the experienced burden for the patient associated with extra MRI and PET-CT scanning in the clinical work-up for esophageal cancer, as determined by a self-administered questionnaire.