NCT06540443RecruitingPhase 1
Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 10 Jul 2024
- Start date
- Dec 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- MegaPro Biomedical Co. Ltd.
- Diseases
- Head and neck cancer
- NCT number
- NCT06540443
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From Dec 2024 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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 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 active hepatitis B or hepatitis C infection.
- Subjects with bone marrow disorders or a history of a bone marrow transplant.
Lab values
- Subjects with liver or spleen disease or impairment based on other clinical imaging, such as CT or gadolinium contrast MRI, and clinical laboratory results.
Other
- Subjects with contraindications to MRI
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.