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/41498537Actively Recruiting
Phase 1
Age: 19Years +
All Genders
ID05945875
Targeted Dual Modality Imaging for Detection and Removal of Head and Neck Cancer
Led by Vanderbilt-Ingram Cancer Center · Updated on 2025-10-03
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with SPECT/CT 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 SPECT/CT 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
Brief Title
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
- Any T stage and any subsite within the head and neck scheduled for surgical resection and neck dissection
- Includes subjects with recurrent disease or a new primary tumor
- Planned elective neck dissection for node-negative or node-positive disease defined by specified clinical criteria
- Hemoglobin level of 9 gm/dL or higher
- White blood cell count greater than 3000/mm^3
- Platelet count of 100,000/mm^3 or higher
- Serum creatinine less than or equal to 1.5 times the upper reference range
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Myocardial infarction, stroke, uncontrolled heart failure, significant liver disease, or unstable angina within 6 months prior to enrollment
- QT prolongation on electrocardiogram (greater than 440 ms in males or greater than 450 ms in females)
- History of infusion reactions to monoclonal antibody therapies
- History of allergies to iodine
- Pregnant or breastfeeding
- Magnesium or potassium levels below normal institutional values
- Use of certain antiarrhythmic medications (class IA or III)
- History or evidence of interstitial pneumonitis or pulmonary fibrosis
- Severe kidney disease or absence of urine production
- Thyroid stimulating hormone level greater than 13 micro international units/mL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
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)
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo standard of care surgical resection with fluorescence imaging to remove the tumor.
1 visit (in-person surgical procedure)
Follow-up
Duration - Up to 15 days post-surgery
Participants are monitored for safety and adverse events following the intervention.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
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Research Team
N
Nicole Jones
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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