Clinical use of USPIO contrast media in the assessment of pelvic lymph node metastasis in rectal cancer.
Key facts
- Where
- Turku, FinnországSee the site
- Phase
- 3. fázis
Where in Finnország
- Varsinais-Suomen hyvinvointialueTurku, FinnországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Varsinais-Suomen hyvinvointialue
- Trial code
- EU 2024-514831-34-00
- Record updated
- 2026. október 13.
- Original description
Assessment of cN-stage accuracy of Ferumoxtran-10-enhanced USPIO-MRI compared to histopathologic pN-stage of newly-diagnosed RC patientsRead full original descriptionShow less
A prospective, open-label, single-center phase 3 superiority study to assess the clinical nodal stage (cN-stage) accuracy of ferumoxtran-10 -enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathologic pN-stage in newly diagnosed rectal cancer (RC) patients, scheduled for direct surgery or short course radiotherapy prior to surgery.
Assessment of cN-stage accuracy of Ferumoxtran-10-enhanced USPIO-MRI compared to histopathologic pN-stage of newly-diagnosed RC patients
Inclusion: Voluntarily given and written informed consent. • Males and females over 18 years of age. • Newly diagnosed rectal cancer patients scheduled for direct surgery or SCRT. • Female subjects must be not of child-bearing potential, defined as postmenopausal for at least 1 year or surgically sterile. • 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: Subjects unable to provide written informed consent • Age under 18 • Metastatic disease • T1-disease • Allergy to Ferumoxtran-10 or known hypersensitivity to Ferumoxtran-10 or its components • Known history of drug allergy (including hypersensitivity) to other parenteral iron products • Prior severe allergic reactions, including severe asthma and acute drug-induced severe reactions • 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) • Breastfeeding or pregnant women • Women of childbearing potential who are not willing to use effective contraceptive precautions against pregnancy • Prior abdominopelvic radiation • Prior abdominopelvic malignancies • Patients deemed too frail for surgery • Contraindications for MRI (ferromagnetic metallic implants, claustrophobia, MR-incompatible pacemakers, MR-incompatible prosthetic heart valves, severe obesity etc.).