Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lymph Node Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MPB-2043 of 0.5 mg/kg | Drug | — | UNRESOLVED |
| MPB-2043 of 1.0 mg/kg | Drug | — | UNRESOLVED |
| MPB-2043 of 2.0 mg/kg | Drug | — | UNRESOLVED |
| MPB-2043 of 3.0 mg/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose cohort 1
- description
- pre- and post-enhanced MRI
- interventionNames
- Drug: MPB-2043 of 0.5 mg/kg
- type
- EXPERIMENTAL
- label
- Dose cohort 2
- description
- pre- and post-enhanced MRI
- interventionNames
- Drug: MPB-2043 of 1.0 mg/kg
- type
- EXPERIMENTAL
- label
- Dose cohort 3
- description
- pre- and post-enhanced MRI
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available