Head and Neck Squamous Cell CarcinomaMAG-NODENCT04803331
SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification
A study testing SPIO-enhanced MRI in people with Head and Neck Squamous Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- SPIO-enhanced MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Jul 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6500 HB
Daphne Driessen, Msc, +31650008371, daphne.driessen@radboudumc.nl
About this study
Official title: 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- SPIO-enhanced MRI
- Keywords
- Sentinel lymph node identification, Magnetic resonance imaging, Superparamagnetic iron oxide, Oral cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIO-enhanced MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: SPIO-enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start27 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J.H.A.M. Kaanders, MD, PhD, Principal investigator, Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803331
- Sponsor's protocol ID
- MAG-NODE study
- Acronym
- MAG-NODE
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41241690
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging for Sentinel Lymph Node Identification in Oral Cancer: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04803331
- Acronym / sponsor ID
- MAG-NODE / MAG-NODE study
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Sentinel lymph node identification, Magnetic resonance imaging, Superparamagnetic iron oxide, Oral cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cT1-2N0M0 oral cancer patients | Experimental | Diagnostic Test: SPIO-enhanced MRIPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPIO-enhanced MRISPIO is peritumorally injected. A T2*-weighted iron sensitive MRI scan is performed 1 hour later to localize and assess the sentinel lymph nodes. | Diagnostic test | cT1-2N0M0 oral cancer patients |
Primary outcome
MR (artefact) finetuning for optimization of SPIO dose and timing of MRI
Time frame: 2 months
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 secondary outcomes
Localization of sentinel lymph nodes detected by conventional 99mTC-nanocollloid injection and SPECT-CT and by SPIO injection and MRI
Time frame: 1 year
Comparison of SPIO distribution within a lymph node on MR-images and histopathological staining.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 41241690Heldens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J.H.A.M. Kaanders, MD, PhD principal investigator
Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIO-enhanced MRI in people with Head and Neck Squamous Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact D.A.J.J. Driessen, MD (+31650008371, daphne.driessen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR (artefact) finetuning for optimization of SPIO dose and timing of MRI (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.