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
| Registry | NCT07741643 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; na, sequential, masking: none, diagnostic |
| Enrollment | 30 (Estimated) |
| Sponsor | Vanderbilt-Ingram Cancer Center (Other) |
| Conditions | HNSCC,Larynx, Pharynx and Oral Cavity, Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Surgery |
| Interventions | Panitumumab-IRDye800, [18F]NOTA-ABY-030 (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2031-07-01 (estimated), completion 2031-07-01 (estimated), first posted 2026-08-03, last updated 2026-10-19 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for HNSCC,Larynx, Pharynx and Oral Cavity All trials for Squamous Cell Carcinoma All trials of Panitumumab-IRDye800 All trials of [18F]NOTA-ABY-030
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 5.0 mCi - [18F]NOTA-ABY-030 and 50 mg - pan800 | Experimental | Drug: Panitumumab-IRDye800; Drug: [18F]NOTA-ABY-030 |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Tennessee | United States | Recruiting |