RecruitingPhase 1NCT06540443

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

Sponsor

MegaPro Biomedical Co. Ltd.

Enrollment

24 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma Lymph Node Metastasis

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.

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a new MRI contrast agent called MPB-2043 to improve the detection of cancerous lymph nodes in the neck for people with head and neck cancers (squamous cell carcinomas). Better imaging could help surgeons decide which lymph nodes need to be removed, potentially avoiding unnecessary surgery. **You may be eligible if...** - You are 20 or older with biopsy-confirmed head and neck squamous cell carcinoma, or suspicious lymph nodes that may contain cancer - You are scheduled for lymph node removal surgery within 8 weeks - You are not breastfeeding **You may NOT be eligible if...** - You have a contraindication to MRI (e.g., certain metal implants) - You have a known allergy to similar contrast agents - You have previously had surgery on the affected lymph nodes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMPB-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.

DRUGMPB-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.

DRUGMPB-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.

DRUGMPB-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

View Full Details on ClinicalTrials.gov

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NCT06540443

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