Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
NCT Number: NCT06540443
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Head and Neck Squamous Cell Carcinoma|Lymph Node Metastasis
Interventions: DRUG: MPB-2043 of 0.5 mg/kg|DRUG: MPB-2043 of 1.0 mg/kg|DRUG: MPB-2043 of 2.0 mg/kg|DRUG: MPB-2043 of 3.0 mg/kg
Sponsor: MegaPro Biomedical Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2025-05
Locations: National Taiwan University Hospital, Taipei, 100, Taiwan

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.

Primary Outcome Measures: 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., Measured at pre-injection (Baseline) and 24 hours post-injection.
Secondary Outcome Measures: 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., 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., 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., 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., 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).', From baseline to Day 28 post-MPB-2043 administration.