Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and... | NCT07741643

NCT07741643

Overview

NCT ID: NCT07741643
Lead Sponsor: Vanderbilt-Ingram Cancer CenterOTHER
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
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Jul 2031Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 30Estimated
Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Makenna BrownContact
makenna.l.brown@vumc.org6154214370

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

Similar Studies