NCT07741643RecruitingPhase 1

Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma

Phase I Open-Label Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn whether using two imaging agents-Panitumumab-IRDye800 (Pan800) and\[18F\]NOTA-ABY-030-is safe and feasible for helping surgeons identify tumors and cancer-containing lymph nodes during surgery in adults with head and neck squamous cell carcinoma (HNSCC) who are scheduled for tumor removal and neck dissection. The main questions it aims to answer are: * Is the combination of Pan800 and \[18F\]NOTA-ABY-030 safe and well tolerated in patients undergoing surgery for HNSCC? * How accurately can Pan800 and \[18F\]NOTA-ABY-030 detect tumor tissue and cancer-positive lymph nodes when compared with final pathology results? This is a single-arm, open-label study, so there is no comparison group. Study Related Steps: * Receive an intravenous infusion of Pan800 1-2 days before surgery. * Receive an intravenous injection of\[18F\]NOTA-ABY-030 on the day of surgery.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 30 (estimated)
First submitted: 6 Jul 2026
Start date: Oct 2026
Primary completion date: Jul 2031
Lead sponsor: Vanderbilt-Ingram Cancer Center
Diseases: Head and neck cancer
NCT number: NCT07741643

What you commit to

Study type: Interventional · Phase 1
Planned participants: 30
From Oct 2026 to the primary completion date, Jul 2031
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

Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.

Other illness

History of infusion reactions to monoclonal antibody therapies.
History of allergies to iodine.
Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
Severe renal disease or anuria.

Lab values

Magnesium or phosphorus lower than the normal institutional values and the patient is symptomatic.

Other

Evidence of QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
Pregnant or breastfeeding.

Who the study is looking for

Age ≥ 18 years.
Subjects diagnosed with any T stage or N stage squamous cell carcinoma and 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.
Have acceptable hematologic status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9 gm/dL
- White blood cell count \> 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
- Ability to understand and the willingness to sign a written informed consent document.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Vanderbilt University Medical Center Coordinator of this site? Confirm its status	Nashville	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.