NCT06540443 Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
| NCT ID | NCT06540443 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | MegaPro Biomedical Co. Ltd. |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-12-19 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Pei-Jen Lou, MD., PhD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT06540443 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06540443 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06540443 currently recruiting?
Yes, NCT06540443 is actively recruiting participants. Contact the research team at jilltsai@megaprobio.com for enrollment information.
Where is the NCT06540443 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06540443 clinical trial?
NCT06540443 is sponsored by MegaPro Biomedical Co. Ltd.. The principal investigator is Pei-Jen Lou, MD., PhD at National Taiwan University Hospital. The trial plans to enroll 24 participants.