Staging before surgery by combidex MRI in patients with resectableesophageal carcinoma

Phase 1

• Conditions: Detection of locoregional lymph node metastases in patients with resectable esophageal carcinoma; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-003133-18-NL
• Lead Sponsor: radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-09
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients with recently biopsy proven esophageal cancer, who are planned to undergo a esophagectomy with nCRT
•Patients with suspected lymph nodes metastases on EUS or CT before nCRT
•Age > 18 years
•Providing informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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
-Known liver or renal insufficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified