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Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03733210
Recruitment Status : Completed
First Posted : November 7, 2018
Last Update Posted : June 22, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eben Rosenthal, Stanford University

Brief Summary:
This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans make detailed, computerized pictures of areas inside the body where the drug is used. Giving panitumumab IRDye800 and 89Zr panitumumab to patients with head and neck cancer may help doctors find metastatic lymph nodes better than current methods [positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations].

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Carcinoma of the Head and Neck Drug: Panitumumab-IRDye800 Drug: Zirconium Zr-89 Panitumumab Device: Pinpoint IR IR9000 flourescence imaging system (FIS) Device: SPY-PHI IR9000 flourescence imaging system (FIS) Device: Explorer Air camera Device: PDE-NEO II camera Device: FIS-00 fluorescence imaging system (FIS) Device: Da Vinci Firefly Imaging System Device: IGP-ELVIS-v4 Macroscopic Specimen Imager Device: Vevo 3100 LAZR-X Device: Pearl Triology Imaging System Device: Odyssey CLx Imaging System Device: Leica fluorescence microscope Phase 1

Detailed Description:

Participants receive standard of care 18F-FDG-PET/CT and/or 18F-FDG-PET/MRI to assess their cancer for surgical excision. Participants than receive panitumumab-IRDye800 dye and 89Zr-panitumumab, both by intravenous (IV) infusion, on Day 0. Participants will undergo 89Zr-panitumumab PET/CT imaging on Day 1 to 2, and then undergo surgical resection of the tumor at 2 to 5 days after infusion. Participants with cancer-positive lymph nodes vs cancer-negative lymph nodes will be analyzed as separate cohorts. Research imaging will be performed intraoperatively using optical imaging devices and a high-energy gamma probe. Subsequently, the excised tissue will evaluated ex vivo (back table) using radioactive (89Zr-panitumumab) and fluorescence (panitumumab-IRDye800) imaging techniques. After surgery, patients are followed up at 15 and 30 days.

PRIMARY OBJECTIVES:

I. Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zr panitumumab) for the detection of tumor-involved regional lymph nodes.

SECONDARY OBJECTIVES:

I. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by 89Zr panitumumab labeling.

EXPLORATORY OBJECTIVES:

I. Determine the sensitivity and specificity of panitumumab IRDye800 for the detection of tumor-involved regional lymph nodes.

II. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by panitumumab-IRdye800 labeling.

optical imaging devices listed in Appendix B intraoperative high-energy gamma probe.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study Evaluating Panitumumab-IRDye800 and 89Zr-Panitumumab for Dual-Modality Imaging for Nodal Staging in Head and Neck Cancer
Actual Study Start Date : January 7, 2019
Actual Primary Completion Date : December 11, 2020
Actual Study Completion Date : August 9, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arm Intervention/treatment
Experimental: Lymph Node-positive Tumor
Participants whose lymph nodes are positive for cancer
Drug: Panitumumab-IRDye800
30 mg administered intravenously (IV)
Other Names:
  • Panitumumab IRDye 800
  • RDye800-Panitumumab Conjugate

Drug: Zirconium Zr-89 Panitumumab
0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)
Other Name: 89Zr-panitumumab (SY); 89Zr-labeled Panitumumab (SY); Zr 89-Panitumumab (SY)

Device: Pinpoint IR IR9000 flourescence imaging system (FIS)
Handheld fluorescence-imaging endoscope manufactured by Novadaq

Device: SPY-PHI IR9000 flourescence imaging system (FIS)
Handheld fluorescence-imaging endoscope manufactured by Novadaq

Device: Explorer Air camera
Fluorescence camera manufactured by SurgVision

Device: PDE-NEO II camera
Medical infrared camera manufactured by Hamamatsu Photonics KK

Device: FIS-00 fluorescence imaging system (FIS)
Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK

Device: Da Vinci Firefly Imaging System
Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc

Device: IGP-ELVIS-v4 Macroscopic Specimen Imager
Macroscopic specimen imager manufactured by LI-COR Biosciences

Device: Vevo 3100 LAZR-X
Photoacoustic ultrasound imaging system manufactured by VisualSonics

Device: Pearl Triology Imaging System
Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences

Device: Odyssey CLx Imaging System
Infrared fluorescent imaging system manufactured by LI-COR Biosciences

Device: Leica fluorescence microscope
Fluorescence microscope manufactured by Leica

Experimental: Lymph Node-negative Tumor
Participants whose lymph nodes are negative for cancer
Drug: Panitumumab-IRDye800
30 mg administered intravenously (IV)
Other Names:
  • Panitumumab IRDye 800
  • RDye800-Panitumumab Conjugate

Drug: Zirconium Zr-89 Panitumumab
0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)
Other Name: 89Zr-panitumumab (SY); 89Zr-labeled Panitumumab (SY); Zr 89-Panitumumab (SY)

Device: Pinpoint IR IR9000 flourescence imaging system (FIS)
Handheld fluorescence-imaging endoscope manufactured by Novadaq

Device: SPY-PHI IR9000 flourescence imaging system (FIS)
Handheld fluorescence-imaging endoscope manufactured by Novadaq

Device: Explorer Air camera
Fluorescence camera manufactured by SurgVision

Device: PDE-NEO II camera
Medical infrared camera manufactured by Hamamatsu Photonics KK

Device: FIS-00 fluorescence imaging system (FIS)
Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK

Device: Da Vinci Firefly Imaging System
Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc

Device: IGP-ELVIS-v4 Macroscopic Specimen Imager
Macroscopic specimen imager manufactured by LI-COR Biosciences

Device: Vevo 3100 LAZR-X
Photoacoustic ultrasound imaging system manufactured by VisualSonics

Device: Pearl Triology Imaging System
Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences

Device: Odyssey CLx Imaging System
Infrared fluorescent imaging system manufactured by LI-COR Biosciences

Device: Leica fluorescence microscope
Fluorescence microscope manufactured by Leica




Primary Outcome Measures :
  1. Number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were predicted to be tumor positive by 89Zr-panitumumab labeling [ Time Frame: Up to 3 years ]
    The number and location of 18F FDG avid nodes within the regional lymphatics will be compared to the number and location of 89Zr-panitumumab avid nodes in relation to the postoperative neck dissection histopathology. The total number of tumor positive nodes will be determined and correlated to the radiologically suspicious nodes identified by 89Zr-panitumumab and 18F-FDG contrast agents using PET/CT and/or PET/MRI imaging.The specificity and sensitivity of 89Zr panitumumab will be calculated and compared to the specificity and sensitivity of 18F FDG for metastatic lymph node identification. Significance will be assessed at the 0.05 level and to assess uncertainty, 95% confidence intervals will be provided for all estimates.


Secondary Outcome Measures :
  1. Number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were not predicted tumor-positive by 89Zr panitumumab labeling [ Time Frame: Up to 3 years ]
    The number and location of 18F-FDG avid nodes within the regional lymphatics will be compared to the number and location of 89Zr-panitumumab avid nodes in relation to the postoperative neck dissection histopathology. Will calculate the odds of a false negative using 89Zr-panitumumab PET relative to the odds of a false negative using a 18F-FDG PET and compare the negative predictive value (NPV) of 89Zr-panitumumab and 18F-FDG. Will present means and standard deviations (or medians and interquartile ranges when appropriate) for continuous characteristics such as SUVmax as determined with 89Zr-panitumumab PET and 18F FDG PET and radioactivity counts of 89Zr-panitumumab in the node(s) as determined with the PET probe.


Other Outcome Measures:
  1. Sensitivity and specificity of panitumumab IRDye800 for the detection of tumor-involved regional lymph nodes [ Time Frame: Up to 3 years ]
    Sensitivity and specificity will be generated by comparison of fluorescence intensity and histological and/or pathological evaluation. Findings will be compared to the sensitivity and specificity of 89Zr panitumumab and 18F FDG (primary objective) using Durkalskis test, as outlined above. For categorical variables such as drainage pattern and number of lymph nodes visualized, will present frequency statistics. Graphical tools such as heat maps, histograms, and boxplots will be used to assess distributional properties of continuous variables. We will illustrate the nature of the relationship between SUVmax/radioactivity counts and/or mean florescence intensity (MFI)/tumor to background ratios (TBRs) and/or drainage pattern across all subjects, the relationship will be illustrated with a heat map and spaghetti plot.

  2. Number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were not predicted tumor-positive by panitumumab-IRdye800 labeling [ Time Frame: Up to 3 years ]
    The level of association will be determined between panitumumab-IRdye800 results and 89Zr-panitumumab PET and 18F FDG PET results with the Phi coefficient. Will present means and standard deviations (or medians and interquartile ranges when appropriate) for continuous characteristics such as TBRs and MFI for panitumumab-IRdye800.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
  • Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
  • Planned standard of care surgery with curative intent for squamous cell carcinoma.
  • 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:

  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
  • Previous bilateral neck dissection.
  • History of infusion reactions to monoclonal antibody therapies.
  • Pregnant or breastfeeding.
  • Magnesium or potassium lower than the normal institutional values.
  • Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
  • Severe renal disease or anuria.
  • Known hypersensitivity to deferoxamine or any of its components.

Information from the National Library of Medicine

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): NCT03733210


Locations
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United States, California
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Eben Rosenthal
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eben Rosenthal, MD Stanford Cancer Institute Palo Alto
  Study Documents (Full-Text)

Documents provided by Eben Rosenthal, Stanford University:
Informed Consent Form  [PDF] August 4, 2020

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Responsible Party: Eben Rosenthal, Professor of Otolaryngology-Head and Neck Surgery and of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT03733210    
Other Study ID Numbers: IRB-41878
NCI-2018-02270 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ENT0066 ( Other Identifier: OnCore Number )
P30CA124435 ( U.S. NIH Grant/Contract )
R01CA190306 ( U.S. NIH Grant/Contract )
IRB-41878 ( Other Identifier: stanford-IRB )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eben Rosenthal, Stanford University:
Head and Neck Cancer
Additional relevant MeSH terms:
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Carcinoma
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Squamous Cell
Neoplasms by Site
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents