Enhanced MRI for detecting lymph node metastasis in head and neck cancer
A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas
This study is testing a new MRI contrast agent to see if it can help doctors better detect cancer spread in lymph nodes for people with head and neck cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | MegaPro Biomedical Co. Ltd. Industry-sponsored |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06540443 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide contrast agent, to improve MRI imaging for detecting metastatic lymph nodes in patients with head and neck squamous cell carcinomas. The study compares four different doses of MPB-2043 and assesses the optimal timing for imaging to enhance the accuracy of nodal staging. By utilizing T1/T2/T2*-weighted MRI sequences, the study aims to differentiate between malignant and non-malignant lymph nodes based on signal intensity changes after administration of the contrast agent.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and above with histologically confirmed head and neck squamous cell carcinomas or suspicious metastatic lymph nodes requiring lymphadenectomy.
Not a fit: Patients with contraindications to MRI or those who have had recent gadolinium-enhanced MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the accuracy of lymph node staging in head and neck cancer, leading to better treatment planning.
How similar studies have performed: While the use of superparamagnetic iron oxide agents has shown promise in other imaging contexts, this specific application for head and neck cancer is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Pei-Jen Lou, MD., PhD — National Taiwan University Hospital
- Study coordinator: Jill Tsai, MD
- Email: jilltsai@megaprobio.com
- Phone: +886-35910360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.