Using dual imaging techniques to detect head and neck cancer

Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of 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.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Vanderbilt-Ingram Cancer Center (other)
• Drugs / interventions: panitumumab
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT05945875 on ClinicalTrials.gov

What this trial studies

This phase I trial evaluates the safety and effectiveness of two imaging techniques, indium In 111 panitumumab with SPECT/CT and panitumumab-IRDye800 fluorescence imaging, for detecting disease in patients with head and neck cancer. Patients will receive these imaging agents prior to undergoing standard surgical resection, allowing for enhanced visualization of tumor cells. The study aims to assess the sensitivity and specificity of these imaging methods in identifying subclinical disease and lymph nodes. Participants will be followed up 15 days after the intervention to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with biopsy-confirmed head and neck squamous cell carcinoma scheduled for surgical resection.

Not a fit: Patients with significant cardiovascular or renal issues, or those who do not meet the inclusion criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the accuracy of disease detection in patients with head and neck cancer, potentially leading to better surgical outcomes.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cancer detection, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

* Age \>= 19 years
* Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed
* Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging
* 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
* Ability to understand and the willingness to sign a written informed consent document

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
* Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
* 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
* Thyroid stimulating hormone (TSH) \> 13 micro international units/mL

Where this trial is running

Nashville, Tennessee

• 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

Conditions: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma