RecruitingPhase 1NCT05945875

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


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

40 participants

Start Date

Oct 3, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two imaging techniques during head and neck cancer surgery — fluorescence imaging and a special light-based microscopy technique — can help surgeons see the cancer more clearly in real time. The goal is to improve the accuracy of removing cancer while sparing healthy tissue. **You may be eligible if...** - You are 19 or older - You have been diagnosed with squamous cell carcinoma of the head and neck (confirmed by biopsy) - You are scheduled for surgery to remove the tumor, including removal of nearby lymph nodes - Your blood counts and kidney function meet the required levels **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy to the imaging agents used in the study - Your cancer has spread to distant parts of the body (metastatic) - You have had prior radiation to the head and neck area that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPanitumumab-IRDye800

Given by IV

OTHERIndium In 111 Panitumumab

Given by IV

PROCEDURESingle Photon Emission Computed Tomography

Undergo Single Photon Emission Computed Tomography

PROCEDUREComputed Tomography

Undergo Computed Tomography

PROCEDUREResection

Undergo standard of care surgical resection

PROCEDUREFluorescence Imaging

Undergo standard of care fluorescence imaging


Locations(1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

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NCT05945875


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