Optimizing Lymph Node Staging in Esophageal Cancer with USPIO-enhanced MRI

Conditions

Esophageal cancer

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGFerrotran Lyophilisate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed