Back to resultsSPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification (MAG-NODE)
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
SPIO-enhanced MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Squamous Cell Carcinoma focused on measuring Sentinel lymph node identification, Magnetic resonance imaging, Superparamagnetic iron oxide, Oral cancer
Eligibility 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:
- 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.
Sites / Locations
- RadboudumcRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cT1-2N0M0 oral cancer patients
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04803331
First Posted
March 4, 2021
Last Updated
October 25, 2022
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04803331
Brief Title
SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification
Acronym
MAG-NODE
Official Title
Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging for Sentinel Lymph Node Identification in Oral Cancer: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
Sentinel lymph node identification, Magnetic resonance imaging, Superparamagnetic iron oxide, Oral cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cT1-2N0M0 oral cancer patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
SPIO-enhanced MRI
Intervention Description
SPIO is peritumorally injected. A T2*-weighted iron sensitive MRI scan is performed 1 hour later to localize and assess the sentinel lymph nodes.
Primary Outcome Measure Information:
Title
MR (artefact) finetuning for optimization of SPIO dose and timing of MRI
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Localization of sentinel lymph nodes detected by conventional 99mTC-nanocollloid injection and SPECT-CT and by SPIO injection and MRI
Description
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.
Time Frame
1 year
Title
Comparison of SPIO distribution within a lymph node on MR-images and histopathological staining.
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
D.A.J.J. Driessen, MD
Phone
+31650008371
Email
daphne.driessen@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.H.A.M. Kaanders, MD, PhD
Organizational Affiliation
Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Driessen, Msc
Phone
+31650008371
Email
daphne.driessen@radboudumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
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SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification
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