Recruiting
Phase 2

Panitumumab-IRDye800

Sponsor:

University of Alabama at Birmingham

Code:

NCT04511078

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Panitumumab-IRDye800

Study Details

Brief summary:

The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.

Conditions

Head and Neck Cancer

Study ID

NCT04511078

Start date

Apr 2, 2021

Status verified date

Dec, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
3. Planned standard of care surgery with curative intent for squamous cell carcinoma
4. Male or female patients age ≥ 18 years
5. Have life expectancy of more than 12 weeks
6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:

1. Hemoglobin ≥ 9 gm/dL
2. Absolute Neutrophil Count ≥ 1500
3. White Blood Cell count > 3000/mm3
4. Platelet count ≥ 100,000/mm3
5. Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
3. History of infusion reactions to any monoclonal antibody therapies
4. Women who are pregnant or breast-feeding
5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
6. Magnesium or potassium lower than the normal institutional values
7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
9. TSH > 13 micro International Units/mL

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Panitumumab-IRDye800

50 mg infusion of panitumumab-IRDye800 given over 60 minutes

Interventions

Panitumumab-IRDye800

single dose infusion of panitumumab-IRDye800CW

Primary outcome measure

  • Tumor to background ratio of fluorescence (TBR) [ Time Frame: Day 0 through Day 15 ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • panitumumab
  • optical imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-24.