Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Tar… (NCT07741643) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
30 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.