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

NCT06540443 · tracked via the Priya Life Science Taiwan tracker

Sponsor

MegaPro Biomedical Co. Ltd

Phase

Phase 1

Started

2024-12-19

Last updated

2025-05-08

Condition(s) studied

Head and Neck Squamous Cell CarcinomaLymph Node Metastasis

Investigational drug(s) / intervention(s)

MPB-2043 of 0.5 mg/kgMPB-2043 of 1.0 mg/kgMPB-2043 of 2.0 mg/kgMPB-2043 of 3.0 mg/kg

MPB-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.

MPB-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.

MPB-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.

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.

Study 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

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Sensitivity and Specificity of MPB-2043 Enhanced MRI in Detecting Lymph Node Metastasis — Measured at pre-injection (Baseline) and 24 hours post-injection.
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.

Trial sites (1)

Facility	City	Region	Status
National Taiwan University Hospital	Taipei	Taiwan	Recruiting

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Other trials for the same condition

A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone Active, not recruiting

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1) Active, not recruiting

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2) Active, not recruiting

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Active, not recruiting

Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06540443 on ClinicalTrials.gov ↗ ← All trials in Taiwan