Actively Recruiting

Phase 1
Age: 20Years +
All Genders
NCT06540443

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

Led by MegaPro Biomedical Co. Ltd. · Updated on 2025-05-08

24

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

Sponsors

M

MegaPro Biomedical Co. Ltd.

Lead Sponsor

N

National Taiwan University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects aged 20 years and above
  • Subjects with histologically proven head and neck squamous cell carcinomas or suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2) without previous surgery treatment
  • Subjects require lymphadenectomy treatment within 8 weeks based on clinical practice
  • Subjects must be nonlactating
  • Subjects must be able to understand and sign informed consent
  • Subjects must be able to follow the study protocol
Not Eligible

You will not qualify if you...

  • Subjects with contraindications to MRI
  • Subjects with serious allergic history or known allergy to similar contrast agents (Gd-based, SPIO particles, iodinated contrast agents)
  • Subjects who had gadolinium-enhanced MRI within 7 days before enrollment
  • Subjects who participated in another imaging-related clinical trial within 30 days before enrollment
  • Subjects with active systemic infections, significant cardiac diseases, gastrointestinal ulcers, or other conditions affecting contrast agent processing
  • Subjects with kidney disease or impairment
  • Subjects with liver or spleen disease or impairment based on imaging or lab results
  • Subjects with active hepatitis B or C infection
  • Subjects with bone marrow disorders or history of bone marrow transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

J

Jill Tsai, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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