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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514831-34-00

Enrollment

Registered

2024-06-24

Start date

2024-09-19

Completion date

Unknown

Last updated

2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer, Mesorectal lymph node metastases

Brief summary

Accuracy

Detailed description

positive predictive value, negative predictive value, sensitivity, specificity.

Interventions

DRUGIRON OXIDE

DRUGNANOPARTICLES

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Accuracy	—

Secondary

Measure	Time frame
positive predictive value, negative predictive value, sensitivity, specificity.	—

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026