Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05901545

Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Vanderbilt-Ingram Cancer Center · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Assess the safety of indium In 111 panitumumab (111In-panitumumab) as a molecular imaging agent in patients with HNSCC. SECONDARY OBJECTIVE: I. Compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to day of surgery versus conventional local injection with an optical dye at the time of surgery. EXPLORATORY OBJECTIVES: I. Determine if systemic injection of 111In-panitumumab can identify tumor-positive lymph nodes on preoperative SPECT/CT. II. When preoperative imaging information (eg, fludeoxyglucose F 18 \[18F-FDG\] positron emission tomography \[PET\]/CT and/or magnetic resonance imaging \[MRI\]) data is available: IIa. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative MRI in identifying metastatic lymph nodes (histopathological results will serve as the gold standard). IIb. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative 18F-FDG PET/CT in identifying metastatic lymph nodes (histopathological results will serve as the gold standard). OUTLINE: Patients receive loading dose of panitumumab intravenously (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 near infrared (NIR) imaging. Patients additionally undergo blood sample collection during screening and electrocardiography (ECG) during screening, on day 0, and on day 15 if indicated. Patients are followed for up to 15 days after last dose of study medication.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPanitumumabGiven by IV
OTHERIndium In 111 PanitumumabGiven by IV
PROCEDURESingle Photon Emission Computed TomographyUndergo SPECT/CT
PROCEDUREComputed TomographyUndergo SPECT/CT
PROCEDURESurgical ProcedureUndergo standard of care surgery
OTHERImaging agentReceive local injection of optical dye
PROCEDUREIntraoperative ImagingUndergo Intraoperative Imaging
PROCEDURENear Infrared ImagingUndergo Near Infrared Imaging
PROCEDUREElectrocardiographyUndergo Electrocardiography
PROCEDUREBiospecimen CollectionUndergo blood sample collection

Timeline

Start date
2023-08-22
Primary completion
2028-11-30
Completion
2029-11-30
First posted
2023-06-13
Last updated
2026-03-05

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05901545. Inclusion in this directory is not an endorsement.