SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification

Head and Neck Squamous Cell Carcinoma Clinical Trial

— MAG-NODE  

Official title:

Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging for Sentinel Lymph Node Identification in Oral Cancer: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803331
• Other study ID #: MAG-NODE study
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2022
• Source: Radboud University Medical Center
• Contact: D.A.J.J. Driessen, MD
• Phone: +31650008371
• Email: daphne.driessen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Squamous Cell Carcinoma
• Mouth Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Diagnostic Test:
• SPIO-enhanced MRI
SPIO is peritumorally injected. A T2*-weighted iron sensitive MRI scan is performed 1 hour later to localize and assess the sentinel lymph nodes.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MR (artefact) finetuning for optimization of SPIO dose and timing of MRI	The first two patients will receive a dose of 0.012 ml SPIO. MR-images will be assessed. If this dose provides satisfactory MR-images (good visualization of lymph nodes without disturbing artefacts), subsequent patients will receive the same dose. If the artefact is too large, the dose will be decreased. If visualization is poor, the dose will be increased. The procedure will be repeated with adjusted doses each time in two patients until satisfactory MR-images are obtained.; The investigators have established timing of MRI 1 hour after SPIO injection. It is assumed that after this time interval SPIO particles have had sufficient time to migrate to the SNs and to be taken up. However, if this interval appears to be too long because 'too many' SNs are visualized the time interval will be shortened. If this interval appears to be too short since no or too little SNs are visualized because SPIO uptake has not taken place yet, the time interval will be lengthened.	2 months
Secondary	Localization of sentinel lymph nodes detected by conventional 99mTC-nanocollloid injection and SPECT-CT and by SPIO injection and MRI	SPIO-enhanced MR-images and SPECT-CT images are compared to investigate whether SPIO-enhanced MRI detects the same sentinel lymph nodes as SPECT-CT.	1 year
Secondary	Comparison of SPIO distribution within a lymph node on MR-images and histopathological staining.	SNs will be localized on T2* weighted SPIO-enhanced in vivo MR-images by a radiologist. Lymph node status will be assessed based on signal intensity. All surgically removed lymph nodes are embedded in a tissue cassette. Histopathological analysis of these lymph nodes includes multiple sectioning, HE staining, immunohistochemistry and iron staining. The MR-images are compared to the pathology slices to see whether the MR signal intensity pattern matches the benign/malignant structure of the lymph node.	1 year