A Phase 1 interventional study of MPB-2043 of 0.5 mg/kg and MPB-2043 of 1.0 mg/kg in Head and Neck Squamous Cell Carcinoma and Lymph Node Metastasis, sponsored by MegaPro Biomedical Co. Ltd.. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by MegaPro Biomedical Co. Ltd. · Phase 1, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
pre- and post-enhanced MRI
Drug: MPB-2043 of 0.5 mg/kg
pre- and post-enhanced MRI
Drug: MPB-2043 of 1.0 mg/kg
pre- and post-enhanced MRI
Drug: MPB-2043 of 2.0 mg/kg
pre- and post-enhanced MRI
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.
Also known as: MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Also known as: MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Also known as: MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Also known as: MPB-2043 enhanced MRI
Sensitivity and Specificity of MPB-2043 Enhanced MRI in Detecting Lymph Node Metastasis
1. Sensitivity is the proportion of true positive lymph nodes (those confirmed as metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change of 20% on T2\*-weighted sequences post-injection is considered indicative of metastasis. 2. Specificity is the proportion of true negative lymph nodes (those confirmed as non-metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change ≥ 50% on T2\*-weighted sequences post-injection is considered indicative of non-metastasis.
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
Changes in Signal Intensity of Lymph Nodes in Head and Neck MRI
This outcome measure will assess and compare the changes in signal intensity (SI) in MRI images of lymph nodes in the head and neck region taken before and after the administration of MPB-2043. The SI changes will be evaluated across T1, T2, and T2\*-weighted sequences.
Time frame: From baseline to 10 minutes post-injection, and 24 hours post-injection.
Number and Size of Lymph Nodes Detected in Head and Neck
This outcome measure will record and evaluate the number and size of lymph nodes detected in the head and neck region/level via MRI post-administration of MPB-2043. The effectiveness of MPB-2043 in enhancing lymph node visibility and characterization will be determined by comparing these parameters before and after administration.
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
Determination of Optimal MPB-2043 Dosage for Lymph Node Imaging in Head and Neck MRI
This outcome measure will determine the most suitable dosage of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, 3 mg/kg) for optimal MRI contrast enhancement of lymph nodes in the head and neck region. The assessment will be based on post-dose MRI results, specifically evaluating signal intensity changes at 24 hours post-administration.
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
Safety Variables of Adverse Events
• The incidence of all adverse events * Treatment-emergent adverse events (AEs) * Serious AEs * Any AEs leading to withdrawal of study treatment * Any AEs leading to study discontinuation * Any AEs leading to death The data will be categorized and reported based on severity (mild, moderate, severe) and relatedness to the study drug, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From baseline to Day 28 post-MPB-2043 administration.
Safety Variables of Clinical Laboratory Tests
Clinical laboratory and vital sign data will be assessed for safety. This outcome measure evaluates the incidence of abnormal findings in clinical laboratory tests following the administration of MPB-2043. The tests include hematology (e.g., complete blood count), biochemistry (e.g., liver and kidney function tests), coagulation profiles (e.g., PT, INR, aPTT), and urinalysis. Results will be categorized as 'Normal,' 'Abnormal, Not Clinically Significant (NCS),' or 'Abnormal, Clinically Significant (CS).'
Time frame: From baseline to Day 28 post-MPB-2043 administration.
Plan to share: No
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MegaPro Biomedical Co. Ltd.