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

ConditionsHead and Neck Squamous Cell CarcinomaLymph Node Metastasis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorMegaPro Biomedical Co. Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MPB-2043 of 0.5 mg/kg

    Drug

    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/kg

    Drug

    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/kg

    Drug

    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/kg

    Drug

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

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Dose cohort 1Experimental treatment 1 intervention
Group B: Dose cohort 2Experimental treatment 1 intervention
Group C: Dose cohort 3Experimental treatment 1 intervention
Group D: Dose cohort 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MegaPro Biomedical Co. Ltd.

Lead sponsor

National Taiwan University Hospital

Collaborator

Source ClinicalTrials.gov
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