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RECRUITING
NCT06540443
PHASE1

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

Sponsor: MegaPro Biomedical Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-12-19

Completion Date

2026-09

Last Updated

2025-05-08

Healthy Volunteers

No

Interventions

DRUG

MPB-2043 of 0.5 mg/kg

Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.

DRUG

MPB-2043 of 1.0 mg/kg

Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.

DRUG

MPB-2043 of 2.0 mg/kg

Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.

DRUG

MPB-2043 of 3.0 mg/kg

Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan