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

NCT04803331 | Unknown

• 1 other identifier: MAG-NODE study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Sentinel lymph node identification; Magnetic resonance imaging; Superparamagnetic iron oxide; Oral cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Localization of sentinel lymph nodes detected by conventional 99mTC-nanocollloid injection and SPECT-CT and by SPIO injection and MRI

  1 year

• Comparison of SPIO distribution within a lymph node on MR-images and histopathological staining.

  1 year

Study Arms (1)

cT1-2N0M0 oral cancer patients

EXPERIMENTAL

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

Interventions

SPIO-enhanced MRI DIAGNOSTIC_TEST

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

cT1-2N0M0 oral cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

Related Publications (1)

• Heldens GTN, Driessen DAJJ, Dijkema T, Arens AIJ, Zamecnik P, Pegge SAH, Weijs WLJ, van Engen-van Grunsven ACH, Takes RP, Kaanders JHAM, Scheenen TWJ. SPIO-enhanced MRI for sentinel lymph node mapping in oral cancer: a prospective feasibility study. Eur Radiol Exp. 2025 Nov 15;9(1):113. doi: 10.1186/s41747-025-00636-4.

  PMID: 41241690 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Study Officials

• J.H.A.M. Kaanders, MD, PhD

  Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

D.A.J.J. Driessen, MD

CONTACT

+31650008371; daphne.driessen@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 17, 2021
• Study Start: July 27, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)