IRON OXIDE, NANOPARTICLES for Rectal cancer | Mesorectal lymph node metastases

Inclusion criteria

• {"criterion_text":"- Voluntarily given and written informed consent."}
• {"criterion_text":"- Males and females over 18 years of age."}
• {"criterion_text":"- Newly diagnosed rectal cancer patients scheduled for direct surgery or SCRT."}
• {"criterion_text":"- Female subjects must be not of child-bearing potential, defined as postmenopausal for at least 1 year or surgically sterile."}
• {"criterion_text":"- Women of childbearing potential (WOCBP) can be included if they take precautions against pregnancy during the study and for at least 3 months thereafter."}

Exclusion criteria

• {"criterion_text":"- Subjects unable to provide written informed consent "}
• {"criterion_text":"- Age under 18 "}
• {"criterion_text":"- Metastatic disease "}
• {"criterion_text":"- T1-disease "}
• {"criterion_text":"- Allergy to Ferumoxtran-10 or known hypersensitivity to Ferumoxtran-10 or its components "}
• {"criterion_text":"- Known history of drug allergy (including hypersensitivity) to other parenteral iron products "}
• {"criterion_text":"- Prior severe allergic reactions, including severe asthma and acute drug-induced severe reactions "}
• {"criterion_text":"- Clinically documented or risk of primary or secondary iron overloading (e.g. history of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple iron transfusions for any reason) "}
• {"criterion_text":"- Breastfeeding or pregnant women "}
• {"criterion_text":"- Women of childbearing potential who are not willing to use effective contraceptive precautions against pregnancy "}
• {"criterion_text":"- Prior abdominopelvic radiation "}
• {"criterion_text":"- Prior abdominopelvic malignancies "}
• {"criterion_text":"- Patients deemed too frail for surgery "}
• {"criterion_text":"- Contraindications for MRI (ferromagnetic metallic implants, claustrophobia, MR-incompatible pacemakers, MR-incompatible prosthetic heart valves, severe obesity etc.)"}

Primary endpoints

• {"endpoint_text":"- Accuracy","definition_or_measurement_approach":"Assessment of cN-stage accuracy of Ferumoxtran-10-enhanced USPIO-MRI compared to histopathologic pN-stage (histopathology as reference standard)."}

Secondary endpoints

• {"endpoint_text":"- positive predictive value, negative predictive value, sensitivity, specificity.","definition_or_measurement_approach":"Diagnostic performance metrics (positive predictive value, negative predictive value, sensitivity, specificity) of cN-stage assessment by Ferumoxtran-10-enhanced USPIO-MRI compared to histopathologic pN-stage."}

Finland

Earliest CTIS Part Ii Submission Date

05-06-2024

Latest Decision Or Authorization Date

24-06-2024

Processing Time Days

19

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Varsinais-Suomen hyvinvointialue

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland