FERUMOXTRAN-10 for Esophageal cancer

Inclusion criteria

• {"criterion_text":"- Histopathological proven cT1-4aN+M0 esophageal adenocarcinoma\n- WHO-performance score between 0-2\n- Scheduled for neoadjuvant chemoradiotherapy and esophagectomy at baseline\n- Aged ≥18 years\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- English and Dutch language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent\n- Use of any other investigational medicinal product within 30 days prior to receiving study medication until last follow-up visit\n- Pregnancy\n- Non-FDG avid tumor at baseline PET-CT\n- Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant, neurostimulator, non-MR compatible implants, patients with severe claustrophobia or otherwise contra indicated\n- Known hypersensitivity to Ferrotran® (or other USPIO holding agents) or its components dextran or Sodium Citrate\n- History of anaphylaxis or hypersensitivity reactions after intravenous administration\n- History of iron overload or disturbances in the utilization of iron (e.g., haemochromatosis, hemosiderosis, chronic hemolytic anemia with frequent blood transfusions)\n- Active inflammatory diseases\n- History of abnormal liver function, or elevated liver enzymes (ALAT or ASAT > 3 times upper limit of normal)\n- History of elevated Serum Transferrin Saturation (TSAT) (>50%) or hemoglobin (>10.5mmol/L)\n- Previous treatment for esophageal cancer"}

Primary endpoints

• {"endpoint_text":"- Observer’s qualitative assessment of image quality for evaluation of lymph node metastases on USPIO-enhanced MR, compared to PET-CT images","definition_or_measurement_approach":"Qualitative assessment by observers comparing USPIO-enhanced MR image quality to PET-CT images."}
• {"endpoint_text":"- Time required for observers to assess USPIO-enhanced MRI, compared to standard PET-CT, in minutes","definition_or_measurement_approach":"Measured time in minutes required by observers to assess USPIO-enhanced MRI versus PET-CT."}
• {"endpoint_text":"- Patient questionnaire for perceived burden of undergoing USPIO-enhanced MRI, compared to PET-CT","definition_or_measurement_approach":"Patient-reported questionnaire assessing perceived burden of USPIO-enhanced MRI compared to PET-CT."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV, likelihood ratio) comparing USPIO-MRI and PET-CT against pathological assessment (reference standard)."}
• {"endpoint_text":"- Lymph node size, shape, number, intensity, location, and fibrotic characteristics","definition_or_measurement_approach":"Descriptive and imaging-based assessment of lymph node characteristics (size, shape, number, intensity, location, fibrotic features) on imaging."}

Secondary endpoints

• {"endpoint_text":"- Complications, (S)AEs, SUSARs, and toxicity from USPIO-infusion","definition_or_measurement_approach":"Collection and reporting of complications, serious and non-serious adverse events, SUSARs, and toxicity related to USPIO infusion."}
• {"endpoint_text":"- Time intervals between all study and standard of care procedures in days","definition_or_measurement_approach":"Measurement in days of time intervals between study procedures and standard-of-care procedures."}
• {"endpoint_text":"- Accuracy (sensitivity, specificity, positive /negative predictive value, and likelihood ratio) of the proposed lymph node scoring system for metastatic suspicion on USPIO-enhanced MRI","definition_or_measurement_approach":"Diagnostic performance metrics (sensitivity, specificity, PPV, NPV, likelihood ratio) for the proposed lymph node scoring system on USPIO-MRI."}

Netherlands

Earliest CTIS Part Ii Submission Date

25-07-2025

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

6

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"SAVING PATIENTS LIVES MEDICAL B.V.","duties_or_roles":"Supplier/manufacturer of Ferrotran Lyophilisate (product listed in Part I)","organisation_type":""}