Using a radioactive drug to find cancer spread in head and neck patients

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 phase I trial evaluates the safety and effectiveness of indium In 111 panitumumab for identifying sentinel lymph nodes in patients with head and neck squamous cell carcinoma (HNSCC) prior to surgery. The study involves administering a loading dose of panitumumab followed by a radioactive agent, 111In-panitumumab, to enhance imaging of lymph nodes. The primary objective is to assess safety, while secondary objectives include comparing the sensitivity and specificity of this method against conventional imaging techniques. The trial aims to improve preoperative detection of lymph node metastases, which is crucial for patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 19 years.
* Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).
* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
* Planned standard of care elective neck dissection for node-negative or node-positive disease.
* Have acceptable hematologic status, kidney function, and liver function including the following clinical results:

  * Hemoglobin ≥ 9 gm/dL
  * White blood cell count \> 3000/mm\^3
  * Platelet count ≥ 100,000/mm\^3
  * Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
* History of infusion reactions to monoclonal antibody therapies
* History of allergies to iodine
* Pregnant or breastfeeding.
* Magnesium or potassium lower than the normal institutional values.
* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
* Severe renal disease or anuria.

Where it's running

• Vanderbilt University/Ingram Cancer Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Eben Rosenthal, MD — Vanderbilt University/Ingram Cancer Center
• Study coordinator: Nicole Jones
• Email: nicole.l.jones@vumc.org
• Phone: 615-936-2807

Similar studies

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

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• Remote hearing tests for patients with head and neck cancer receiving chemotherapy or radiation

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• Combination treatment for advanced head and neck cancer

  This study is testing a new combination treatment for people with advanced head and neck cancer to see if it can boost their immune response and help fight the disease.

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• Using dual imaging techniques to detect head and neck cancer

  This study is testing two new imaging techniques to see if they can better detect head and neck cancer in patients before surgery.

  Recruiting Phase 1 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT05945875

• Using a new imaging agent to detect metastases in head and neck cancer

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  Recruiting Phase 1 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT05747625

• Combination of immunotherapy and chemotherapy for head and neck cancer treatment

  This study is testing if combining an immunotherapy drug with chemotherapy before and after surgery can help people with head and neck cancer do better.

  Recruiting Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT05726370

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.