NCT06540443

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: MegaPro Biomedical Co. Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The accurate detection of metastatic lymph nodes in subjects with head and neck squamous cell carcinomas is essential for appropriate staging and treatment planning. Traditional imaging techniques often struggle with detecting small nodal metastases due to limitations in resolution and contrast. Superparamagnetic iron oxide (SPIO) particles, such as MPB-2043, have shown promise as MRI contrast agents, particularly in the detection of metastatic lesions in the liver. This study extends the application of SPIO-enhanced MRI to the detection of metastatic cervical lymph nodes. In this study, T1/T2/T2\*-weighted MRI sequences will be used to assess signal intensity (SI) changes in lymph nodes after the administration of MPB-2043. The susceptibility effects of the iron oxide core cause tissue signal loss, which is more pronounced in normal lymph nodes taken up by the reticuloendothelial system, allowing for differentiation from malignant lymph nodes. The study will evaluate the safety and effectiveness of four different doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) in enhancing the visualization of cervical lymph nodes and will determine the most appropriate timing for post-dose imaging. The primary objectives include determining the dose that provides optimal contrast enhancement without compromising safety and identifying the time points post-injection that offer the best differentiation between malignant and non-malignant lymph nodes. The results of this pilot feasibility study will inform the development of more extensive clinical trials aimed at improving the diagnostic accuracy of MRI in patients with head and neck squamous cell carcinomas.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Lymph Node Metastasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-19
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2024-08-06
• Last updated: 2025-05-08

Locations

1 site across 1 country: Taiwan