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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

NCT07741643 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-03

No results posted yet for this study

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

Interventions

DRUG

Panitumumab-IRDye800

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

DRUG

[18F]NOTA-ABY-030

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

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2031-07-31
Completion
2031-07-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741643 on ClinicalTrials.gov