Panitumumab IRDye800 Optical Imaging Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02415881|
Recruitment Status : Suspended (Logistics)
First Posted : April 14, 2015
Last Update Posted : August 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Panitumumab IRDye 800 Device: da Vinci Firefly Device: IMAGE1 + ICG Hopkins telescope and/or VITOM||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Panitumumab IRDye 800
Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.
Drug: Panitumumab IRDye 800
Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery
Other Name: Optical Imaging prior to surgery
Device: da Vinci Firefly
Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology)
Device: IMAGE1 + ICG Hopkins telescope and/or VITOM
IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery.
- Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events [ Time Frame: 30 days ]Safety profile of panitumumab conjugated to IRDye800CW (panitumumab IRDye800) will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.
- Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio [ Time Frame: 7 days ]Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio. Fluorescence intensity of tumor tissue compared to that of normal surrounding tissue.
- Optimal timing of the surgical procedure to maximize tumor to background ratio [ Time Frame: 7 days ]Fluorescence intensity of tissue obtained from patients undergoing surgery at different time points in various cohorts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415881
|United States, Alabama|
|University of Alabama at Birmingham Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Stanford University, School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Eben L Rosenthal, MD||Stanford University|