Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorMegaPro Biomedical Co. Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MPB-2043 of 0.5 mg/kg
- MPB-2043 of 1.0 mg/kg
- MPB-2043 of 2.0 mg/kg
- MPB-2043 of 3.0 mg/kg
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
MegaPro Biomedical Co. Ltd.
Lead sponsor
National Taiwan University Hospital
Collaborator
Source ClinicalTrials.gov