Status:
UNKNOWN
Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma
Lead Sponsor:
Radboud University Medical Center
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the diagnostic accuracy of USPIO enhanced MRI for the detection of lymph node metastases in head-and-neck squamous cell carcinoma (SCC) using histopathology as a gold standard.
Detailed Description
The presence of lymph node metastases has a large impact on prognosis and treatment in head-and neck cancer patients and necessitates treatment intensification. Determining lymph node status, however,...
Eligibility Criteria
Inclusion
- Patients with histopathologically proven cT0-4N0-3M0 SCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown primary.
- Patients planned to undergo a neck dissection.
- Patient provided written informed consent.
Exclusion
- Patients who underwent radio- and/or chemotherapy to the neck before surgery.
- Patients who had a previous lymphadenectomy in the head and neck region.
- Patients with contraindications to MRI (epilepsy; claustrophobia; metallic splinters; pacemaker, pacemaker wires or implanted defibrillator; implanted magnets in jaw; arterial clips (carotid arteries); pregnancy; auditory implant, neurogenic bladder stimulator, insulin pump, neurostimulator, baclofen pump; metallic tissue expander after mastectomy; cochlear implant; metallic braces; other foreign bodies implanted)
- Patients with contraindications to USPIO based contrast agents (prior allergic reaction to ferumoxtran-10 or any other iron preparation; prior allergic reaction attributed to dextran or other polysaccharide, in any preparation; hereditary hemochromatosis, hemosiderosis, chronic hemolytic anaemia (e.g. thalassemia, sickle cell anaemia); pregnancy)
- Unable to provide informed consent.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03817307
Start Date
May 20 2019
End Date
April 1 2023
Last Update
October 26 2022
Active Locations (1)
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1
Radboudumc
Nijmegen, Netherlands