Evaluating a new imaging agent for head and neck cancer staging
Pilot Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
This study is testing a new imaging agent to see if it can better identify important lymph nodes in patients with head and neck cancer before surgery compared to the usual method.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | panitumumab |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04840472 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety of 111In-panitumumab as a molecular imaging agent in patients with head and neck squamous cell carcinoma. It aims to compare the effectiveness of this agent in identifying sentinel lymph nodes through systemic injection before surgery versus the conventional method of local injection with an optical dye at the time of surgery. Participants will undergo SPECT/CT scans to evaluate the imaging results. The study is designed for patients scheduled for surgical resection of their cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-confirmed head and neck squamous cell carcinoma scheduled for surgical resection.
Not a fit: Patients with significant comorbidities such as uncontrolled heart failure or severe liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of lymph node staging in head and neck cancer, leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promise in using molecular imaging agents for cancer staging, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Subjects with recurrent disease or a new primary will be allowed. * Planned standard of care elective neck dissection for a cN0 or cN1 disease. Clinical N1 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. * Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: * Hemoglobin ≥ 9 gm/dL * White blood cell count \> 3000/mm3 * Platelet count ≥ 100,000/mm3 * 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. * 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 this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Fred Baik, MD — Stanford Universiy
- Study coordinator: Erik Chan
- Email: erikchan@stanford.edu
- Phone: 650-725-9333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.