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

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

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Diagnostic test: SPIO-enhanced MRI

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: D.A.J.J. Driessen, MD; Phone Number: +31650008371; Email: daphne.driessen@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Recruiting
      • Radboudumc
      • Contact: Daphne Driessen, Msc; Phone Number: +31650008371; Email: daphne.driessen@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cT1-2N0M0 oral cancer patients; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: J.H.A.M. Kaanders, MD, PhD, Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Oral cancer; Superparamagnetic iron oxide; Sentinel lymph node identification
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms
• Other Study ID Numbers: MAG-NODE study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No