Recruiting
Phase 1

111In-Panitumumab & Panitumumab-IRDye800

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT05945875

Conditions

Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Panitumumab-IRDye800

Indium In 111 Panitumumab

Single Photon Emission Computed Tomography

Computed Tomography

Resection

Study Details

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Study ID

NCT05945875

Start date

Oct 3, 2023

Status verified date

Sep, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  • Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
  • History of infusion reactions to monoclonal antibody therapies
  • History of allergies to iodine
  • Pregnant or breastfeeding
  • Magnesium or potassium lower than the normal institutional values
  • Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Severe renal disease or anuria
  • Thyroid stimulating hormone (TSH) > 13 micro international units/mL

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Panitumumab-IRDye800

Given by IV

Indium In 111 Panitumumab

Given by IV

Single Photon Emission Computed Tomography

Undergo Single Photon Emission Computed Tomography

Computed Tomography

Undergo Computed Tomography

Resection

Undergo standard of care surgical resection

Fluorescence Imaging

Undergo standard of care fluorescence imaging

Primary outcome measure

  • Number of grade 2 or higher adverse events [ Time Frame: Up to day 15 ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Vanderbilt-Ingram Service Services for Timely Access

800-811-8480

Principal Investigator:

Eben Rosenthal, MD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Oct 3, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2025-10-03.