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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
ClinicalTrials.gov ID: NCT06540443
What this study is testing
What is MPB-2043 of 0.5 mg/kg?
MPB-2043 of 0.5 mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma.
Also referred to as MPB-2043 enhanced MRI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- people aged 20 years and above
- people with histologically proven head and neck squamous cell carcinomas or with suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2)...
- Based on the site's clinical practice, people require lymphadenectomy treatment within 8 weeks.
- people must be nonlactating.
- people must be able to understand and be willing to sign a written informed consent document.
You likely can't join if
- people with contraindications to MRI
- people with a serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e., Gd-based, SPIO particles, and...
- people obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment.
- people who participated in another imaging-related clinical trial 30 days prior to the study enrollment.
- people with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions...
- people with kidney disease or impairment.
See the full eligibility criteria
- people aged 20 years and above
- people 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, people require lymphadenectomy treatment within 8 weeks.
- people must be nonlactating.
- people must be able to understand and be willing to sign a written informed consent document.
- people must be able to comply with the study protocol.
- people with contraindications to MRI
- people 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).
- people obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment.
- people who participated in another imaging-related clinical trial 30 days prior to the study enrollment.
- people with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and...
- people with kidney disease or impairment.
- people with liver or spleen disease or impairment based on other clinical imaging, such as CT or gadolinium contrast MRI, and clinical laboratory results.
- people with active hepatitis B or hepatitis C infection.
- people with bone marrow disorders or a history of a bone marrow transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.