SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification (MAG-NODE)

Radboud University Medical Center

Status: Unknown

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Diagnostic Test: SPIO-enhanced MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04803331

MAG-NODE study

Details and patient eligibility

About

To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

cT1-2N0M0 oral cancer patients

Experimental group

Description:

Patients undergo routine sentinel lymph node procedure (99mTc injection, planar imaging, SPECT-CT and surgery) for clinical purposes. After 99mTc injections and imaging has been executed peritumoral SPIO injections are performed by a medical doctor. A T2\*-weighted iron sensitive MRI scan is made 1 hour later.

Treatment:

Diagnostic Test: SPIO-enhanced MRI