Status:
UNKNOWN
SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification
Lead Sponsor:
Radboud University Medical Center
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.
Eligibility Criteria
Inclusion
- Male or female aged \>18 years.
- Patients with histopathologically proven cT1-2N0M0 squamous cell carcinoma of the oral cavity.
- Patients planned to undergo routine sentinel node biopsy with 99mTc-radioisotope and SPECT-CT.
- Patient provided written informed consent.
Exclusion
- Patients who underwent previous surgery or radiotherapy to the neck.
- Contra-indications to SPIO (Hypersensitivity to iron oxide or dextran compounds, Presence of iron overload disease (hereditary hemochromatosis, hemosiderosis, chronic hemolytic anemia (e.g. thalassemia, sickle cell anemia))
- Contra-indications to MRI: Epilepsy, Claustrophobia, Metallic splinters, Pacemaker, pacemaker wires or implanted defibrillator, Implanted magnets in jaw, Metallic 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
- Unable to provide informed consent.
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04803331
Start Date
July 27 2021
End Date
July 1 2023
Last Update
October 26 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500 HB