Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas
MegaPro Biomedical Co. Ltd.
24 participants
Dec 19, 2024
INTERVENTIONAL
Conditions
Summary
This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. The study compares four doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) and assesses the optimal timing for post-dose imaging using T1/T2/T2\*-weighted sequences to improve the accuracy of nodal staging.
Eligibility
Inclusion Criteria6
- Subjects aged 20 years and above
- Subjects with histologically proven head and neck squamous cell carcinomas or with suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2) without previous treatment by surgery
- Based on the site's clinical practice, subjects require lymphadenectomy treatment within 8 weeks.
- Subjects must be nonlactating.
- Subjects must be able to understand and be willing to sign a written informed consent document.
- Subjects must be able to comply with the study protocol.
Exclusion Criteria9
- Subjects with contraindications to MRI
- Subjects with a serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e., Gd-based, SPIO particles, and iodinated contrast agents).
- Subjects obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment.
- Subjects who participated in another imaging-related clinical trial 30 days prior to the study enrollment.
- Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.
- Subjects with kidney disease or impairment.
- Subjects with liver or spleen disease or impairment based on other clinical imaging, such as CT or gadolinium contrast MRI, and clinical laboratory results.
- Subjects with active hepatitis B or hepatitis C infection.
- Subjects with bone marrow disorders or a history of a bone marrow transplant.
Interventions
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06540443