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

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Age \>= 19 years

• Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck

• Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed

• Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging

• 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

• Ability to understand and the willingness to sign a written informed consent document

Locations
United States
Tennessee
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Contact Information
Primary
Nicole Jones
nicole.l.jones@vumc.org
615-936-2807
Time Frame
Start Date: 2023-10-03
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)
Patients receive panitumumab-IRDye800 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.
Sponsors
Leads: Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov