SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification
NCT ID: NCT04803331
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2021-07-27
2023-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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J.H.A.M. Kaanders, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radiation Oncology
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MAG-NODE study
Identifier Type: -
Identifier Source: org_study_id
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