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Imaging with 111In Panitumumab 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 five years
Awards & highlights
Study Summary
This trial tests a new imaging technique to help identify cancer spread to lymph nodes in head and neck cancer patients before surgery, potentially improving survival.
Who is the study for?
This trial is for adults over 19 with a confirmed diagnosis of head and neck squamous cell carcinoma, who are scheduled for surgical resection. They must have acceptable blood counts, kidney and liver function, but can't join if they've had recent severe heart issues, allergies to iodine or monoclonal antibodies, low magnesium or potassium levels, certain antiarrhythmic drugs in their system, or severe kidney problems.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of a radioactive drug called indium In 111 panitumumab (111In-panitumumab) combined with SPECT/CT imaging to identify sentinel lymph nodes affected by cancer in patients undergoing surgery for head and neck cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion of monoclonal antibodies like panitumumab. Since it's a radioactive agent used for imaging purposes during surgery, there might be risks associated with radiation exposure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events grade 2 or higher
Secondary outcome measures
Sensitivity of systemic injection of indium In 111 panitumumab (111In-panitumumab) for identifying sentinel lymph nodes
Specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)Experimental Treatment10 Interventions
Patients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Near Infrared Imaging
2013
Completed Phase 1
~10
Electrocardiography
2014
N/A
~150
Panitumumab
2020
Completed Phase 3
~7130
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Computed Tomography
2017
Completed Phase 2
~2720
Surgical Procedure
2020
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,903 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,425 Total Patients Enrolled
Eben Rosenthal, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center
7 Previous Clinical Trials
8,101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a neck surgery to remove lymph nodes.My cancer is a type of skin cancer in the head or neck area, and it hasn't spread to my lymph nodes.My blood, kidney, and liver tests meet the required levels.I haven't had a heart attack, stroke, severe heart failure, liver disease, or unstable chest pain in the last 6 months.I am 19 years old or older.I am taking medication for heart rhythm problems.I have had interstitial pneumonitis or pulmonary fibrosis.I am scheduled for surgery for my head or neck cancer, including if it has returned or is a new occurrence.I have severe kidney problems or cannot produce urine.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
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 there any open enrollment opportunities for this experiment?
"Clinicaltrials.gov shows this medical trial has ceased enrollment as of June 4th 2023, although it was initially posted on July 1st the same year. At present, there are 2,997 other clinical trials recruiting participants."
Answered by AI
Has the FDA provided clearance for Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)?
"With limited data on its efficacy and safety, our team at Power assessed the Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) with a score of 1."
Answered by AI
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