Frontlight ResearchEarly access
Taking people in FinlandPhase 3
Ferumoxtran-10 MRI scans to check lymph nodes in rectal cancer
Compares a contrast-enhanced MRI scan with a standard scan to check rectal cancer spread.
Key facts
- Who runs it
- Varsinais-Suomen hyvinvointialue
- Where
- Turku, FinlandSee the site
- Registry title
- Clinical use of USPIO contrast media in the assessment of pelvic lymph node metastasis in rectal cancer.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 60 people, planned
- Started
- 19 Sept 2024
- Expected to end
- 31 Aug 2027
- Type of study
- Interventional
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed rectal cancer who are scheduled for direct surgery or short course radiotherapy. It tests an MRI scan with the contrast agent ferumoxtran-10.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- Newly diagnosed rectal cancer, scheduled for direct surgery or short course radiotherapy (SCRT). No metastatic disease and no T1-disease.
- Earlier treatment
- No prior radiation of the abdomen and pelvis.
Main reasons for not taking part
- Metastatic disease or T1-disease
- Allergy to Ferumoxtran-10 or to other iron products
- Risk of iron overload, for example thalassemia or sickle cell anemia
- Prior abdominopelvic radiation or prior abdominopelvic malignancies
- Pregnant or breastfeeding women, or a contraindication for MRI
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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.)
Where in Finland
- Varsinais-Suomen hyvinvointialueTurku, FinlandTaking people
About the trial
What the trial wants to find out
Assessment of cN-stage accuracy of Ferumoxtran-10-enhanced USPIO-MRI compared to histopathologic pN-stage of newly-diagnosed RC patients
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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.
- Plain-language title
- Ferumoxtran-10 MRI scans to check lymph nodes in rectal cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 13 October 2026