Enhanced MRI for detecting lymph node metastasis in head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study tests a pre-surgery treatment combining targeted therapy, immunotherapy, and chemotherapy to see if it helps patients with locally advanced, resectable head and neck squamous cell carcinoma.

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• Online Sharing for Head & Neck Cancer Support

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• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

  This study tests a combination treatment to see if it helps people with newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma who express the c-Met protein.

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• Mild heat therapy added to standard treatment for locally advanced head and neck cancer

  This early-stage trial tests whether mild hyperthermia can be safely added to standard radiotherapy with or without chemotherapy for locally advanced head and neck cancer.

  Recruiting Phase 1 Erasmus Medical Center · Rotterdam, South Holland · NCT07690618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.