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Dual Imaging for Head and Neck Cancer
Phase 1
Recruiting
Led By Eben Rosenthal, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial uses two imaging techniques to detect cancer in head & neck. 111In-panitumumab with SPECT/CT & panitumumab-IRDye800 fluorescence imaging, to improve detection of disease.
Who is the study for?
This trial is for adults over 19 with any stage of head and neck squamous cell carcinoma, scheduled for surgery. It includes those with recurrent disease or a new primary cancer who can sign consent. Excluded are pregnant individuals, those with certain heart risks, severe kidney issues, recent serious cardiovascular events, allergies to iodine or past bad reactions to monoclonal antibodies.Check my eligibility
What is being tested?
The trial tests two imaging techniques in detecting head and neck cancer during surgery: a radioactive agent (111In-panitumumab) used with SPECT/CT scans and a fluorescent dye-linked antibody (panitumumab-IRDye800). The goal is to see if combining these methods improves disease detection.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the imaging agents or dyes used, as well as typical risks associated with exposure to radiation from the SPECT/CT scan such as nausea and increased risk of future cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of grade 2 or higher adverse events
Secondary outcome measures
Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes
Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins
Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)Experimental Treatment6 Interventions
Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Resection
2023
Completed Phase 2
~420
Panitumumab-IRDye800
2019
Completed Phase 2
~20
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Fluorescence Imaging
2014
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,893 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,401 Total Patients Enrolled
Eben Rosenthal, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center
7 Previous Clinical Trials
8,091 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had interstitial pneumonitis or pulmonary fibrosis.I am taking specific medications for heart rhythm problems.I have severe kidney problems or cannot produce urine.I am 19 years old or older.I have been diagnosed with squamous cell carcinoma in my head or neck.I am scheduled for surgery to remove a tumor in my head or neck, including if it's a recurrence or a new primary tumor.I am scheduled for neck surgery to remove lymph nodes due to my cancer.I haven't had a heart attack, stroke, severe heart failure, serious liver disease, or unstable chest pain in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being accepted into this research project?
"Contrary to what one might assume, this clinical trial is presently not accepting subjects. It was first posted on August 15th 2023 with the last edit occurring July 13th 2023. Despite this circumstance, there are a great many other trials actively recruiting participants at this time - 3030 in total."
Answered by AI
Are there any potential risks associated with Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) use in patients?
"Data on the safety and efficacy of Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) is still limited; hence it received a score of 1."
Answered by AI
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