Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas

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 Criteria:

* 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 Criteria:

* 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.

Conditions3

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