NCT05945875

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

Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of Head and Neck Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT/CT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT/CT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.

Detailed description

Primary Objective: \- Assess the safety of the dual modality imaging (DMI) molecular agents, indium In 111 panitumumab (111In-panitumumab) and panitumumab-IRDye800, in patients with head and neck squamous cell carcinoma (HNSCC). SECONDARY OBJECTIVES: * Determine the sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for the detection of subclinical disease during primary tumor removal. * Determine sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for detection of lymph nodes. OUTLINE: Patients receive panitumumab-IRDye800 intravenously (IV) over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging. After completion of study intervention, patients are followed up at day 15.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Panitumumab-IRDye800	Given by IV
OTHER	Indium In 111 Panitumumab	Given by IV
PROCEDURE	Single Photon Emission Computed Tomography	Undergo Single Photon Emission Computed Tomography
PROCEDURE	Computed Tomography	Undergo Computed Tomography
PROCEDURE	Resection	Undergo standard of care surgical resection
PROCEDURE	Fluorescence Imaging	Undergo standard of care fluorescence imaging

Timeline

• Start date: 2023-10-03
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2023-07-14
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study