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

NCT05945875 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: VICC-EDHAN23204PNCI-2023-051241R01CA266233-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of grade 2 or higher adverse events

  Will assess the number of grade 2 or higher adverse events determined to be significant and definitely or probably related to the study drugs. Adverse events will be evaluated using the Common Terminology Criteria for Adverse Events version 5.0 and summarized by grade, severity, and type.

  Up to day 15

Secondary Outcomes (4)

• Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins

  Up to 4 years

• Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins

  Up to 4 years

• Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes

  Up to 4 years

• Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes

  Up to 4 years

Study Arms (1)

Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)

EXPERIMENTAL

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.

Drug: Panitumumab-IRDye800; Other: Indium In 111 Panitumumab; Procedure: Single Photon Emission Computed Tomography; Procedure: Computed Tomography; Procedure: Resection; Procedure: Fluorescence Imaging

Interventions

Panitumumab-IRDye800 DRUG

Given by IV

Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)

Indium In 111 Panitumumab OTHER

Given by IV

Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)

Single Photon Emission Computed Tomography PROCEDURE

Undergo Single Photon Emission Computed Tomography

Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)

Computed Tomography PROCEDURE

Undergo Computed Tomography

Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)

Resection PROCEDURE

Undergo standard of care surgical resection

Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)

Fluorescence Imaging PROCEDURE

Undergo standard of care fluorescence imaging

Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203, United States

RECRUITING

Related Publications (1)

• Burns CR, Mattingly AS, Ely K, Radevic A, Meeks N, Zaidi SMA, Brown B, Vasiukov G, Topf M, Rosenthal E. Intraoperative Molecular Imaging Can Detect Large Nerve Perineural Invasion: A Case Report. Head Neck. 2026 Jan 7. doi: 10.1002/hed.70160. Online ahead of print.

  PMID: 41498537 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Indium; Optical Imaging

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Eben Rosenthal, MD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Jones

CONTACT

615-936-2807; nicole.l.jones@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Department of Otolaryngology-

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (1)