Clinical use of USPIO magnetic imaging contrast media in the assessment of pelvic lymph node metastasis in rectal cancer patients.

Clinical use of USPIO contrast media in the assessment of pelvic lymph node metastasis in rectal cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000827-11-FI

Enrollment

Registered

2022-04-19

Start date

2022-09-02

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Pelvic lymph node metastasis in rectal cancer.

Interventions

Product Name: Ferrotran Lyophilisate Product Code: Ferumoxtran-10 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Ferumoxtran-10 CAS Number: 189047-99-2 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Voluntarily given and written informed consent. Over 18 years of age. Newly-diagnosed rectal cancer patients scheduled for direct surgery or short course radiotherapy (SCRT) followed by surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Metastatic disease or T1-disease. Allergy to hypersensitivity to Ferumoxtran-10 or its components. Patients with any known history of drug allergy (including hypersensitivity) to other iron products. Clinically documented or risk of primary or secondary iron overloading (e.g. history of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple transfusions with any reason). Patients refusing or unable to give informed consent. Lactation or pregnant women. Women of childbearing potential cannot be included if they dont't take precautions against pregnancy. Prior abdominopelvic radiation. Prior abdominopelvic malignancies. Contraindications for MRI (ie. ferromagnetic metallic implants, claustrophobia, MR-incompatible pacemakers, MR-incompatible prosthetic heart valves, severe obesity etc.).

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of clinical nodal stage (cN-stage) accuracy of Ferumoxtran-10-enhanced (USPIO) Magnetic Resonance Imaging (MRI) compared to histopatologic pN-stage of newly-diagnosed rectal cancer (RC) patients;Secondary Objective: Effect of Ferumoxtran-10-enhanced (USPIO) Magnetic Resonance Imaging (MRI) cN-stage assesment on treatment planning compared to conventrional MRI.;Primary end point(s): Accuracy, spesificity and sensitivity of USPIO-MRI.;Timepoint(s) of evaluation of this end point: After TME-surgery.	—

Measure

Time frame

Main Objective: Assessment of clinical nodal stage (cN-stage) accuracy of Ferumoxtran-10-enhanced (USPIO) Magnetic Resonance Imaging (MRI) compared to histopatologic pN-stage of newly-diagnosed rectal cancer (RC) patients;Secondary Objective: Effect of Ferumoxtran-10-enhanced (USPIO) Magnetic Resonance Imaging (MRI) cN-stage assesment on treatment planning compared to conventrional MRI.;Primary end point(s): Accuracy, spesificity and sensitivity of USPIO-MRI.;Timepoint(s) of evaluation of this end point: After TME-surgery.

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Secondary

Measure	Time frame
Secondary end point(s): After TME-surgery.;Timepoint(s) of evaluation of this end point: 1 to 4 week after USPIO-MRI.	—

Countries

Finland

Contacts

Public ContactDepartment of Radiology

Turku University Hospital

+358023133950

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026