NCT04511078RecruitingPhase 2
Phase II Panitumumab-IRDye800 in Head & Neck Cancer
Phase II Open-Label Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 10 Aug 2020
- Start date
- 2 Apr 2021
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Head and neck cancer
- NCT number
- NCT04511078
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 2 Apr 2021 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
- Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Other illness
- History of infusion reactions to any monoclonal antibody therapies
- Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Lab values
- Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
- Magnesium or potassium lower than the normal institutional values
Other
- Women who are pregnant or breast-feeding
- TSH \> 13 micro International Units/mL
Who the study is looking for
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
- 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.
- Planned standard of care surgery with curative intent for squamous cell carcinoma
- Male or female patients age ≥ 18 years
- Have life expectancy of more than 12 weeks
- Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
- Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9 gm/dL
- Absolute Neutrophil Count ≥ 1500
- White Blood Cell count \> 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.