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To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| D.A.J.J. Driessen, MD | Contact | +31650008371 | daphne.driessen@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| J.H.A.M. Kaanders, MD, PhD | Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41241690 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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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 |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |