SYFae180f17bb1949748e8fe67e73bc5d15Registry ID: 2023-506952-26-01|Not Yet RecruitingPhase 2
Optimizing Lymph Node Staging in Esophageal Cancer with USPIO-enhanced MRI
Amsterdam UMCCTIS (EMA)
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interventional
N/A
1 country
1
The primary objectives of this study are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 22, 2025
Actual (reported)Observer’s qualitative assessment of image quality for evaluation of lymph node metastases on USPIO-enhanced MR, compared to PET-CT images
Time required for observers to assess USPIO-enhanced MRI, compared to standard PET-CT, in minutes
Patient questionnaire for perceived burden of undergoing USPIO-enhanced MRI, compared to PET-CT
Accuracy (sensitivity, specificity, positive /negative predictive value, and likelihood ratio) of detecting lymph node metastases on USPIO-enhanced MRI, compared to PET-CT, with pathological assessment as reference standard
Lymph node size, shape, number, intensity, location, and fibrotic characteristics
Complications, (S)AEs, SUSARs, and toxicity from USPIO-infusion
Time intervals between all study and standard of care procedures in days
Accuracy (sensitivity, specificity, positive /negative predictive value, and likelihood ratio) of the proposed lymph node scoring system for metastatic suspicion on USPIO-enhanced MRI
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Amsterdam UMC
Amsterdam, 1081 HV, Netherlands
Dr. S.S. Gisbertz
First Submitted
April 22, 2025
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