Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
NCT ID: NCT06540443
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2024-12-19
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
Study Groups
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Dose cohort 1
pre- and post-enhanced MRI
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.
Dose cohort 2
pre- and post-enhanced MRI
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.
Dose cohort 3
pre- and post-enhanced MRI
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.
Dose cohort 4
pre- and post-enhanced MRI
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
MegaPro Biomedical Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Pei-Jen Lou, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IOP-CT-006
Identifier Type: -
Identifier Source: org_study_id
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