Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients with Head and Neck Cancer

Launched by VANDERBILT-INGRAM CANCER CENTER · Jul 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect head and neck cancer using two advanced imaging techniques. The goal is to find out if combining these methods—one that uses a special radioactive agent called 111In-panitumumab with a type of scan called SPECT/CT, and another that uses a fluorescent dye linked to a similar agent during surgery—can help doctors see cancer more clearly. This trial is for adults aged 19 and older who have been diagnosed with squamous cell carcinoma of the head and neck and are scheduled for surgery.

Participants in this trial will receive the imaging agents before their surgery, and the doctors will use the imaging results to help identify cancerous tissues during the operation. To join the trial, participants must meet certain health criteria, such as having a specific type of cancer and being in good enough health to undergo surgery. Importantly, those with certain heart conditions, severe allergies, or other significant health issues won't be eligible. Throughout the trial, participants will be monitored closely to ensure their safety. This study could potentially improve how doctors detect cancer during surgery, which may lead to better outcomes for patients.

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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