Intraoperative Molecular Imaging Can Detect Large Nerve Perineural Invasion: A Case Report.
Carleigh R Burns, Aviva S Mattingly, Kim Ely...
https://pubmed.ncbi.nlm.nih.gov/41498537/Actively Recruiting
Led by Vanderbilt-Ingram Cancer Center · Updated on 2025-10-03
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the safety and effectiveness of two imaging techniques, indium In 111 panitumumab 111In-panitumumab with SPECTCT and panitumumab-IRDye800 fluorescence imaging during surgery, for detecting disease in patients with head and neck squamous cell carcinoma. This phase I trial focuses on how well these dual imaging agents identify tumor cells and lymph nodes, aiming to improve disease detection during surgical removal. The study is sponsored by the Vanderbilt-Ingram Cancer Center and targets patients scheduled for surgery with this type of cancer. Participants receive panitumumab-IRDye800 intravenously over 15 minutes followed by an IV dose of 111In-panitumumab on day 0. Between days 1 and 5, patients undergo SPECTCT scans before having standard surgical tumor removal combined with fluorescence imaging. This dual modality imaging approach combines radioactive and fluorescent agents to help surgeons better visualize cancerous tissue during operations. During the study, researchers monitor patients for adverse effects up to day 15 to assess safety. They also evaluate the imaging agents sensitivity and specificity in detecting tumor margins and involved lymph nodes, with follow-up outcome measurements extending up to four years. Participants undergo standard blood tests and imaging, and their progress is closely observed to determine how well the imaging techniques work and their safety over time.
CONDITIONS
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer
N
Nicole Jones
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Vanderbilt-Ingram Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational dual imaging | Standard intraoperative assessment |
|---|---|---|
| What it is | An investigational dual intraoperative imaging technique combining panitumumab‑IRDye800 and 111In‑panitumumab visualized with near‑infrared fluorescence imaging and SPECT/CT during surgery | Standard surgical visualization with white‑light and intraoperative frozen section histology for margin and lymph node assessment |
| Role in trial | Used intraoperatively during tumor resection to improve visualization of tumor margins and lymph nodes | Provides the usual clinical pathway against which the investigational method is compared |
| Primary use | To detect tumor‑involved margins and lymph nodes during surgery in real time | To guide surgical decisions and confirm margin status based on visual inspection and tissue sampling |
| How it is performed | Patients receive IV panitumumab‑IRDye800 and 111In‑panitumumab before surgery; real‑time fluorescence imaging and SPECT/CT performed during resection | Surgeons use white‑light visualization during resection and send samples for frozen section histology for margin assessment |
| Evidence status | Early case reports and feasibility studies suggest panitumumab‑IRDye800 fluorescence may detect perineural and bony tumor extension beyond visible margins | Widely used but limited by time‑consuming frozen sections and risk of misclassification |
| Important risks | Potential infusion reactions, risks of IV monoclonal antibody conjugates, radiation exposure from 111In | Risks primarily relate to standard surgical and anesthesia procedures; not increased by imaging pathway |
| Important limitations | Investigational technique not yet validated in large studies and may require specialized imaging hardware and expertise | Frozen section analysis is time‑consuming, operator‑dependent, and may miss microscopic disease |
| Patient impact | May enable more accurate detection of tumor margins during surgery potentially reducing re‑operations | Provides established surgical guidance though limitations may contribute to incomplete resections |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 days
Participants receive two imaging agents intravenously on day 0, followed by specialized imaging between days 1 and 5 before surgery.
2 visits (1 infusion visit and 1 imaging visit)
Duration - 1 day
Participants undergo standard of care surgical resection with fluorescence imaging to remove the tumor.
1 visit (in-person surgical procedure)
Duration - Up to 15 days post-surgery
Participants are monitored for safety and adverse events following the intervention.
1 follow-up visit
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Carleigh R Burns, Aviva S Mattingly, Kim Ely...
https://pubmed.ncbi.nlm.nih.gov/41498537/Vanderbilt-Ingram Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor