Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
Recruiting
Phase 1
Interventional Study
Head and Neck Squamous Cell Carcinoma
Lymph Node Metastasis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 20 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 24 (estimated)
- Sponsor
- MegaPro Biomedical Co. Ltd. · Industry
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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 no…
Trial Locations
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Eligibility Criteria
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 requ…
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