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

NCT ID: NCT05945875

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2028-12-31

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.

Detailed Description

Primary Objective:

• Assess the safety of the dual modality imaging (DMI) molecular agents, indium In 111 panitumumab (111In-panitumumab) and panitumumab-IRDye800, in patients with head and neck squamous cell carcinoma (HNSCC).

SECONDARY OBJECTIVES:

• Determine the sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for the detection of subclinical disease during primary tumor removal.
• Determine sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for detection of lymph nodes.

OUTLINE:

Patients receive panitumumab-IRDye800 intravenously (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.

After completion of study intervention, patients are followed up at day 15.

Conditions

Head and Neck Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Panitumumab-IRDye800

Intervention Type: DRUG

Given by IV

Indium In 111 Panitumumab

Intervention Type: OTHER

Given by IV

Single Photon Emission Computed Tomography

Intervention Type: PROCEDURE

Undergo Single Photon Emission Computed Tomography

Computed Tomography

Intervention Type: PROCEDURE

Undergo Computed Tomography

Resection

Intervention Type: PROCEDURE

Undergo standard of care surgical resection

Fluorescence Imaging

Intervention Type: PROCEDURE

Undergo standard of care fluorescence imaging

Interventions

Panitumumab-IRDye800

Given by IV

Intervention Type: DRUG

Indium In 111 Panitumumab

Given by IV

Intervention Type: OTHER

Single Photon Emission Computed Tomography

Undergo Single Photon Emission Computed Tomography

Intervention Type: PROCEDURE

Computed Tomography

Undergo Computed Tomography

Intervention Type: PROCEDURE

Resection

Undergo standard of care surgical resection

Intervention Type: PROCEDURE

Fluorescence Imaging

Undergo standard of care fluorescence imaging

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Eben Rosenthal

Professor and Chair Department of Otolaryngology-

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eben Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University/Ingram Cancer Center

Locations

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole Jones

Role: CONTACT

nicole.l.jones@vumc.org

615-936-2807

Facility Contacts

Vanderbilt-Ingram Service Services for Timely Access

Role: primary

800-811-8480

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2023-05124

Identifier Type: REGISTRY

Identifier Source: secondary_id

1R01CA266233-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC-EDHAN23204P

Identifier Type: -

Identifier Source: org_study_id