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Panitumumab IRDye800 Optical Imaging Study

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ClinicalTrials.gov Identifier: NCT02415881
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Eben Rosenthal, Stanford University

Tracking Information
First Submitted Date  ICMJE March 26, 2015
First Posted Date  ICMJE April 14, 2015
Last Update Posted Date September 24, 2021
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date November 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
Number of subjects in a cohort experiencing an adverse event that is possibly, probably or definitely related and clinically significant. [ Time Frame: 15 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
  • Highest tumor to background ratio identifiable when comparing cancer to normal surrounding tissue. [ Time Frame: 1 year ]
  • Number of days to produce the optimal timing of the surgical procedure to maximize tumor to background ratio [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Panitumumab IRDye800 Optical Imaging Study
Official Title  ICMJE 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
Brief Summary Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.
Detailed Description This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Panitumumab IRDye 800
Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.
Interventions:
  • Drug: Panitumumab IRDye 800
  • Device: da Vinci Firefly
  • Device: IMAGE1 + ICG Hopkins telescope and/or VITOM
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2021)
64
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2015)
43
Actual Study Completion Date  ICMJE September 21, 2021
Actual Primary Completion Date November 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
  • Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
  • Planned standard of care surgery with curative intent for squamous cell carcinoma
  • Age ≥ 19 years
  • Have life expectancy of more than 12 weeks
  • Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
  • Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: Hemoglobin ≥ 9 gm/dL; White blood cell count > 3000/mm3; Platelet count ≥ 100,000/mm3; Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria

  • Received an investigational drug within 30 days prior to first dose of panitumumab IRDye800
  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  • History of infusion reactions monoclonal antibody therapies
  • Pregnant or breastfeeding
  • Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
  • Magnesium or potassium lower than the normal institutional values
  • Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  • Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • TSH > 13 micro International Units/mL
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02415881
Other Study ID Numbers  ICMJE IRB-35064
ENT0050 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eben Rosenthal, Stanford University
Study Sponsor  ICMJE Eben Rosenthal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eben L Rosenthal, MD Stanford University
PRS Account Stanford University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP