Recruiting
Phase 1

Pan800 & [18F]NOTA-ABY-030

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT07741643

Conditions

HNSCC,Larynx, Pharynx and Oral Cavity

Squamous Cell Carcinoma

Head and Neck Cancer

Head and Neck Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Panitumumab-IRDye800

[18F]NOTA-ABY-030

Study Details

Brief 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 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.

Conditions

HNSCC,Larynx, Pharynx and Oral Cavity

Squamous Cell Carcinoma

Head and Neck Cancer

Head and Neck Surgery

Study ID

NCT07741643

Start date

Oct, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years.
2. 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.
3. 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.

Exclusion Criteria:

1. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
2. Evidence of QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
3. History of infusion reactions to monoclonal antibody therapies.
4. History of allergies to iodine.
5. Pregnant or breastfeeding.
6. Magnesium or phosphorus lower than the normal institutional values and the patient is symptomatic.
7. Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
8. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
9. Severe renal disease or anuria.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 5.0 mCi - [18F]NOTA-ABY-030 and 50 mg - pan800

Interventions

Panitumumab-IRDye800

IV Infusion of 50 mg dose of Panitumumab-IRDye800 (Pan800) 1-2 days before surgery.

[18F]NOTA-ABY-030

Single intravenous bolus injection of approximately 5 mCi (±10%) in the operating room prior to tumor removal and neck dissection.

Primary outcome measure

  • 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. [ Time Frame: Up to 30 Days ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Oct 19, 2026

Last verified

Jul, 2026

Keywords

  • SCC
  • HNSCC
  • Oral Cavity
  • Fluorescent Guided Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.