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Superparamagnetic iron oxide-enhanced magnetic resonance imaging for sentinel lymph node identification in oral cancer: a feasibility study

Superparamagnetic iron oxide-enhanced magnetic resonance imaging for sentinel lymph node identification in oral cancer: a feasibility study - MAG-NODE study

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51046
Enrollment
10
Registered
2021-05-11
Start date
2021-07-27
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral cancer Oral cavity carcinoma

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Patients who underwent previous surgery or radiotherapy to the neck. Contra-indications to SPIO: - prior allergic reaction to SPIO or any other iron preparation - prior allergic reaction contributed to dextran or other polysaccharide, in any preparation - prior allergic reaction to contrast media of anytype - hereditary hemochromatosis, thalassemia, sickle cell anemia Patients unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Feasibility of SPIO-enhanced MRI for SN detection in oral cancer patients: - To optimize dose of SPIO injection - To optimize the timing of MRI - To assess whether SNs detected by conventional 99mTC-nanocollloid injection and SPECT-CT are concordant with those visualized by SPIO injection and MRI

Secondary

MeasureTime frame
- To assess the distribution of SPIO within a lymph node by comparing in vivo MR-images and histopathological staining

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)