Clinical use of USPIO magnetic imaging contrast media in the assessment of pelvic lymph node metastasis in rectal cancer patients.
- Conditions
- Pelvic lymph node metastasis in rectal cancer.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2021-000827-11-FI
- Lead Sponsor
- Turku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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.).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method