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

Phase 1RecruitingNCT06540443

MegaPro Biomedical Co. Ltd.24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Interventions

MPB-2043 of 0.5 mg/kgDRUG

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

MPB-2043 of 1.0 mg/kgDRUG

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

MPB-2043 of 2.0 mg/kgDRUG

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

MPB-2043 of 3.0 mg/kgDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects aged 20 years and above * Subjects with histologically proven head and neck squamous cell carcinomas or with suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2) without previous treatment by surgery * Based on the site's clinical practice, subjects require lymphadenectomy treatment within 8 weeks. * Subjects must be nonlactating. * Subjects must be able to understand and be willing to sign a written informed consent document. * Subjects must be able to comply with the study protocol. Exclusion Criteria: * Subjects with contraindications to MRI * Subjects with a serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e., Gd-based, SPIO particles, and iodinated contrast agents). * Subjects obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment. * Subjects who participated in another imaging-related clinical trial 30 days prior to the study enrollment. * Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent. * Subjects with kidney disease or impairment. * Subjects with liver or spleen disease or impairment based on other clinical imaging, such as CT or gadolinium contrast MRI, and clinical laboratory results. * Subjects with active hepatitis B or hepatitis C infection. * Subjects with bone marrow disorders or a history of a bone marrow transplant.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts