Sign in
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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