HNSCC,Larynx, Pharynx and Oral CavityPhase 1NCT07741643
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
A Phase 1 study testing Panitumumab-IRDye800 and [18F]NOTA-ABY-030 in people with HNSCC,Larynx, Pharynx and Oral Cavity and Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC,Larynx, Pharynx and Oral Cavity, Squamous Cell Carcinoma, Head and Neck Cancer
- What is being tested?
- Panitumumab-IRDye800 and [18F]NOTA-ABY-030
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jul 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
- History of infusion reactions to monoclonal antibody therapies.
- History of allergies to iodine.
- Pregnant or breastfeeding.
- Magnesium or phosphorus lower than the normal institutional values and the patient is symptomatic.
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- Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Severe renal disease or anuria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nicole Jones contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Makenna Brown, 615-421-4370, makenna.l.brown@vumc.org
Nicole Jones, 615-936-2807, nicole.l.jones@vumc.org
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- HNSCC,Larynx, Pharynx and Oral Cavity, Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Surgery
- Being tested
- Panitumumab-IRDye800, [18F]NOTA-ABY-030
- Keywords
- SCC, HNSCC, Oral Cavity, Fluorescent Guided Surgery
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Laryngeal Diseases, Carcinoma, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab-IRDye800Drug
IV Infusion of 50 mg dose of Panitumumab-IRDye800 (Pan800) 1-2 days before surgery.
[18F]NOTA-ABY-030Drug
Single intravenous bolus injection of approximately 5 mCi (±10%) in the operating room prior to tumor removal and neck dissection.
| Study group | Role | What they receive |
|---|---|---|
| 5.0 mCi - [18F]NOTA-ABY-030 and 50 mg - pan800 | Experimental | Not described Receives: Drug: Panitumumab-IRDye800; Drug: [18F]NOTA-ABY-030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record and evaluate the number events considered clinically significant Grade ≥2 AEs that are considered possibly, probably, or definitely related to [¹⁸F]NOTA-ABY-030, pan800, or both agents.
Measured: Up to 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCC,Larynx, Pharynx and Oral CavityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eben Rosenthal, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741643
- Sponsor's protocol ID
- VICCHNP26039
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not plan to share individual participant data from this phase 1 study due to its exploratory nature with a new drug. Sharing individual-level data at this stage could compromise participant confidentiality and may not yield meaningful insights given the preliminary scope of the study.