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

NCT06540443 | Recruiting Phase 1 DMC

• 1 other identifier: IOP-CT-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma; Lymph Node Metastasis

Outcome Measures

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.

  Measured at pre-injection (Baseline) and 24 hours post-injection.

Secondary Outcomes (5)

• Changes in Signal Intensity of Lymph Nodes in Head and Neck MRI

  From baseline to 10 minutes post-injection, and 24 hours post-injection.

• Number and Size of Lymph Nodes Detected in Head and Neck

  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

  Measured at pre-injection (Baseline) and 24 hours post-injection.

• Safety Variables of Adverse Events

  From baseline to Day 28 post-MPB-2043 administration.

• Safety Variables of Clinical Laboratory Tests

  From baseline to Day 28 post-MPB-2043 administration.

Study Arms (4)

Dose cohort 1

EXPERIMENTAL

pre- and post-enhanced MRI

Drug: MPB-2043 of 0.5 mg/kg

Dose cohort 2

EXPERIMENTAL

pre- and post-enhanced MRI

Drug: MPB-2043 of 1.0 mg/kg

Dose cohort 3

EXPERIMENTAL

pre- and post-enhanced MRI

Drug: MPB-2043 of 2.0 mg/kg

Dose cohort 4

EXPERIMENTAL

pre- and post-enhanced MRI

Drug: MPB-2043 of 3.0 mg/kg

Interventions

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.

Also known as: MPB-2043 enhanced MRI

Dose cohort 1

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.

Also known as: MPB-2043 enhanced MRI

Dose cohort 2

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.

Also known as: MPB-2043 enhanced MRI

Dose cohort 3

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.

Also known as: MPB-2043 enhanced MRI

Dose cohort 4

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MegaPro Biomedical Co. Ltd.: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-Jen Lou, MD., PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Tsai, MD

CONTACT

+886-35910360; jilltsai@megaprobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 6, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)