Status:
RECRUITING
Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
Lead Sponsor:
MegaPro Biomedical Co. Ltd.
Collaborating Sponsors:
National Taiwan University Hospital
Conditions:
Head and Neck Squamous Cell Carcinoma
Lymph Node Metastasis
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
The accurate detection of metastatic lymph nodes in subjects with head and neck squamous cell carcinomas is essential for appropriate staging and treatment planning. Traditional imaging techniques oft...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06540443
Start Date
December 19 2024
End Date
September 1 2026
Last Update
May 8 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100