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RECRUITING
NCT05945875
PHASE1

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

Sponsor: Vanderbilt-Ingram Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-10-03

Completion Date

2028-12-31

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

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

Locations (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States