Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
2 other identifiers
interventional
30
1 country
1
Brief Summary
This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2023
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2023
CompletedFirst Posted
Study publicly available on registry
June 13, 2023
CompletedStudy Start
First participant enrolled
August 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2029
March 5, 2026
February 1, 2026
5.3 years
June 4, 2023
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events grade 2 or higher
Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Summarized by grade, severity and type
Up to 15 days after administration of study drug
Secondary Outcomes (2)
Sensitivity of systemic injection of indium In 111 panitumumab (111In-panitumumab) for identifying sentinel lymph nodes
Up to five years
Specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes
Up to five years
Study Arms (1)
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
EXPERIMENTALPatients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Interventions
Undergo SPECT/CT
Undergo standard of care surgery
Receive local injection of optical dye
Undergo Intraoperative Imaging
Undergo Near Infrared Imaging
Undergo Electrocardiography
Undergo blood sample collection
Given by IV
Undergo SPECT/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Cancer Society, Inc.collaborator
- Vanderbilt-Ingram Cancer Centerlead
Study Sites (1)
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eben Rosenthal, MD
Vanderbilt University/Ingram Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 4, 2023
First Posted
June 13, 2023
Study Start
August 22, 2023
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2029
Last Updated
March 5, 2026
Record last verified: 2026-02