pilot study evaluating panitumumab-irdye800 and
sample size justification and power

Since this is an early Phase I study, power considerations are limited but even so, we have excellent power to detect differences in specificity. With 14 subjects and an average of 30 nodes per subject, we expect 420 specimens on which to calculate and compare sensitivity and specificity. However, in calculating power, we must account for the clustering or correlation of lymph nodes within subject. Although we will use Durkalski's test to compare sensitivities and specificities, we estimated power by first determining the effective sample size (ESS), adjusting for the correlation of LNs within person, and then estimated power using McNemar's test on this ESS. We assumed an intra-class correlation of 0.005, yielding an effective sample size of 367 LNs. With an effective sample size of 367, a prevalence of 7.5%,
a significance level of 0.05, and a 0.3 proportion of discordant pairs, we have greater than 95% power to detect a 0.1 difference in specificities, assuming the lower specificity is 0.7. Similarly, we have greater than 71% power to detect a 0.25 difference in sensitivity with the one-sided McNemar test. This assumes the proportion of discordant pairs is 0.3 and the lower sensitivity is 0.7.  
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12. Pedersen NJ, Jensen DH, Hedbäck N, Frendø M, Kiss K, Lelkaitis G, et al. Staging of early lymph node metastases with the sentinel lymph node technique and predictive factors in T1/T2 oral cavity cancer: A retrospective single-center study. Head Neck. 2016 Apr;38 Suppl 1:E1033-1040.  
13. Robbins KT, Ferlito A, Shah JP, Hamoir M, Takes RP, Strojan P, et al. The evolving role of selective neck dissection for head and neck squamous cell carcinoma. Eur Arch Oto-Rhino-Laryngol Off J Eur Fed Oto-Rhino-Laryngol Soc EUFOS Affil Ger Soc Oto-Rhino-Laryngol - Head Neck Surg. 2013 Mar;270(4):1195–202.  
14. Thompson CF, St John MA, Lawson G, Grogan T, Elashoff D, Mendelsohn AH. Diagnostic value of sentinel lymph node biopsy in head and neck cancer: a meta-analysis. Eur Arch Oto-Rhino-Laryngol Off J Eur Fed Oto-Rhino-Laryngol Soc EUFOS Affil Ger Soc Oto-Rhino-Laryngol - Head Neck Surg.  
2013 Jul;270(7):2115–22.  
15. Alvarez Amézaga J, Barbier Herrero L, Pijoan del Barrio JI, Martín Rodríguez JC, Romo Simón L,
Genolla Subirats J, et al. Diagnostic efficacy of sentinel node biopsy in oral squamous cell carcinoma. Cohort study and meta-analysis. Med Oral Patol Oral Cirugia Bucal. 2007 May 1;12(3):E235-243.  
16. Valsecchi ME, Silbermins D, de Rosa N, Wong SL, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in patients with melanoma: a meta-analysis. J Clin Oncol Off J Am Soc Clin Oncol. 2011 Apr 10;29(11):1479–87.  
17. Byers RM, Weber RS, Andrews T, McGill D, Kare R, Wolf P. Frequency and therapeutic implications of "skip metastases" in the neck from squamous carcinoma of the oral tongue. Head Neck. 1997 Jan;19(1):14–9.  
18. Civantos FJ, Moffat FL, Goodwin WJ. Lymphatic mapping and sentinel lymphadenectomy for 106 head and neck lesions: contrasts between oral cavity and cutaneous malignancy. The Laryngoscope. 2006 Mar;112(3 Pt 2 Suppl 109):1–15.  
19. Stoeckli SJ. Sentinel node biopsy for oral and oropharyngeal squamous cell carcinoma of the head and neck. The Laryngoscope. 2007 Sep;117(9):1539–51.  
20. Day KE, Beck LN, Deep NL, Kovar J, Zinn KR, Rosenthal EL. Fluorescently labeled therapeutic antibodies for detection of microscopic melanoma. The Laryngoscope. 2013 Nov;123(11):2681–9.  
21. Heath CH, Deep NL, Beck LN, Day KE, Sweeny L, Zinn KR, et al. Use of panitumumab-IRDye800 to image cutaneous head and neck cancer in mice. Otolaryngol--Head Neck Surg Off J Am Acad Otolaryngol-Head Neck Surg. 2013 Jun;148(6):982–90.  
22. Kulbersh BD, Duncan RD, Magnuson JS, Skipper JB, Zinn K, Rosenthal EL. Sensitivity and specificity of fluorescent immunoguided neoplasm detection in head and neck cancer xenografts. Arch Otolaryngol Head Neck Surg. 2007 May;133(5):511–5.  
23. Withrow KP, Gleysteen JP, Safavy A, Skipper J, Desmond RA, Zinn K, et al. Assessment of indocyanine green-labeled cetuximab to detect xenografted head and neck cancer cell lines.  
Otolaryngol--Head Neck Surg Off J Am Acad Otolaryngol-Head Neck Surg. 2007 Nov;137(5):729–34.  
24. Withrow KP, Newman JR, Skipper JB, Gleysteen JP, Magnuson JS, Zinn K, et al. Assessment of bevacizumab conjugated to Cy5.5 for detection of head and neck cancer xenografts. Technol Cancer Res Treat. 2008 Feb;7(1):61–6.  
25. Grootendorst MR, Cariati M, Pinder SE, Kothari A, Douek M, Kovacs T, et al. Intraoperative Assessment of Tumor Resection Margins in Breast-Conserving Surgery Using (18)F-FDG Cerenkov Luminescence Imaging: A First-in-Human Feasibility Study. J Nucl Med Off Publ Soc Nucl Med. 2017 Jun;58(6):891–8.  
26. de Boer E, Warram JM, Tucker MD, Hartman YE, Moore LS, de Jong JS, et al. In Vivo Fluorescence Immunohistochemistry: Localization of Fluorescently Labeled Cetuximab in Squamous Cell Carcinomas. Sci Rep. 2015 Jun 29;5:10169.  
27. Do K, Cao L, Kang Z, Turkbey B, Lindenberg ML, Larkins E, et al. A Phase II Study of Sorafenib Combined With Cetuximab in EGFR-Expressing, KRAS-Mutated Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2015 Sep;14(3):154–61.  
28. Lindenberg L, Adler S, Turkbey IB, Mertan F, Ton A, Do K, et al. Dosimetry and first human experience with (89)Zr-panitumumab. Am J Nucl Med Mol Imaging. 2017;7(4):195–203.  
29. van Keulen S, Nishio N, Fakurnejad S, Birkeland A, Martin BA, Lu G, et al. The Clinical Application of Fluorescence-Guided Surgery in Head and Neck Cancer. J Nucl Med Off Publ Soc Nucl Med. 2019;60(6):758–63.  
30. van Keulen S, Nishio N, Birkeland A, Fakurnejad S, Martin B, Forouzanfar T, et al. The Sentinel Margin: Intraoperative Ex Vivo Specimen Mapping Using Relative Fluorescence Intensity. Clin Cancer Res Off J Am Assoc Cancer Res. 2019 Aug 1;25(15):4656–62.  
31. van Keulen S, Nishio N, Fakurnejad S, van den Berg NS, Lu G, Birkeland A, et al. Intraoperative Tumor Assessment Using Real-Time Molecular Imaging in Head and Neck Cancer Patients. J Am Coll Surg. 2019 Dec;229(6):560-567.e1.  
32. Nishio N, van den Berg NS, van Keulen S, Martin BA, Fakurnejad S, Teraphongphom N, et al. Optical molecular imaging can differentiate metastatic from benign lymph nodes in head and neck cancer.  
Nat Commun. 2019 Nov 6;10(1):5044.  
33. Cohen R, Stammes MA, de Roos IH, Stigter-van Walsum M, Visser GW, van Dongen GA. Inert coupling of IRDye800CW to monoclonal antibodies for clinical optical imaging of tumor targets.  
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34. Dean NR, Newman JR, Helman EE, Zhang W, Safavy S, Weeks DM, et al. Anti-EMMPRIN monoclonal antibody as a novel agent for therapy of head and neck cancer. Clin Cancer Res Off J Am Assoc Cancer Res. 2009 Jun 15;15(12):4058–65.  
35. Day KE, Sweeny L, Kulbersh B, Zinn KR, Rosenthal EL. Preclinical comparison of near-infrared-labeled cetuximab and panitumumab for optical imaging of head and neck squamous cell carcinoma. Mol Imaging Biol MIB Off Publ Acad Mol Imaging. 2013 Dec;15(6):722–9.  
36. Rosenthal EL, Warram JM, de Boer E, Chung TK, Korb ML, Brandwein-Gensler M, et al. Safety and Tumor Specificity of Cetuximab-IRDye800 for Surgical Navigation in Head and Neck Cancer. Clin Cancer Res Off J Am Assoc Cancer Res. 2015 Aug 15;21(16):3658–66.  
37. McNEMAR Q. Note on the sampling error of the difference between correlated proportions or percentages. Psychometrika. 1947 Jun;12(2):153–7.  
38. Stock C., Hielscher T (2014). DTComPair: comparison of binary diagnostic tests in a paired study design. R package version 1.0.3. URL: http://CRAN.R-project.org/package=DTComPair.  
39. R Core Team (2017). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.  
40. Pei, J., Juniper, G., van den Berg, N.S. et al. Safety and Stability of Antibody-Dye Conjugate in Optical Molecular Imaging. Mol Imaging Biol. 2020. https://doi.org/10.1007/s11307-020-01536-2.
pilot study evaluating panitumumab-irdye800 and
appendices appendix a participant eligibility

A Participant Eligibility Checklist will be completed in its entirety for each subject prior to registration.  
The completed, signed, and dated checklist will be retained in the subject's study file and the study's Regulatory Binder.  
The study coordinator, treating physician and an independent reviewer will verify that the participant's eligibility is accurate, complete, and legible in source records. A description of the eligibility verification process should be included in the EPIC or other Electronic Medical Record progress note.  
| Protocol Title:                                        | Pilot study evaluating Panitumumab-Irdye800 and 89Zr-Panitumumab  for dual-modality imaging for nodal staging in head and neck cancer   |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Protocol Number:                                       | IRB-41878 / OnCore# ENT0066                                                                                                             |
| Principal  Investigator:                               | Andrei Iagaru, MD                                                                                                                       |
| II. Subject Information: Subject Name/ID: Gender: Male | Female                                                                                                                                  |  
III. Study Information:
SRC Approved IRB Approved Contract signed  
| III. Inclusion/Exclusion Criteria Inclusion Criteria (From IRB approved protocol)   | Yes                                                                                                                                                                                                                                                                                  | No        | Supporting Documentation*   |          |      |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------------------------|----------|------|
| 1.                                                                                  | Biopsy-confirmed                                                                                                                                                                                                                                                                     | diagnosis | of                          | squamous | cell |
| carcinoma of the head and neck                                                      |                                                                                                                                                                                                                                                                                      |           |                             |          |      |
| 2.                                                                                  | 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                                                                                      |           |                             |          |      |
| 3.                                                                                  | Planned standard of care surgery with curative intent  for squamous cell carcinoma                                                                                                                                                                                                   |           |                             |          |      |
| 4.                                                                                  | Age ≥ 19 years                                                                                                                                                                                                                                                                       |           |                             |          |      |
| 5.                                                                                  | Have acceptable hematological status, coagulation  status, kidney function, and liver function including  the following clinical results: -Hemoglobin ≥ 9gm/dL -White blood cell count > 3000/mm3 -Platelet count ≥ 100,000/mm3 -Serum creatinine ≤ 1.5 times upper reference  range |           |                             |          |      |  
| Exclusion Criteria                                                                            | Yes                                                   | No                | Supporting Documentation*   |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------|-----------------------------|
| (From IRB approved protocol)                                                                  |                                                       |                   |                             |
| Myocardial                                                                                    | infarction (MI);                                      | cere brovas cular |                             |
| 1.                                                                                            | accident (CVA); uncontrolled congestive heart failure |                   |                             |
| (CHF); significant liver disease; or unstable angina                                          |                                                       |                   |                             |
| within 6 months prior to enrollment                                                           |                                                       |                   |                             |
| Previous bilateral neck dissection.                                                           |                                                       |                   |                             |
| 2.                                                                                            |                                                       |                   |                             |
| 3.                                                                                            | History of infusion reactions to other monoclonal     |                   |                             |
| antibody therapies                                                                            |                                                       |                   |                             |
| 4.                                                                                            | Pregnant or breastfeeding                             |                   |                             |
| Magnesium or potassium lower than the normal                                                  |                                                       |                   |                             |
| 5.                                                                                            | institutional values                                  |                   |                             |
| Subjects receiving Class IA (quinidine, procainamide)                                         |                                                       |                   |                             |
| 6.                                                                                            | Class Ill (dofetilide, amiodarone, sotalol)           |                   |                             |
| or                                                                                            |                                                       |                   |                             |
| antiarrhythmic agents                                                                         |                                                       |                   |                             |
| Subjects with a history or evidence of interstitial                                           |                                                       |                   |                             |
| 7.                                                                                            | pneumonitis or pulmonary fibrosis                     |                   |                             |
| Severe renal disease or anuria                                                                |                                                       |                   |                             |
| 8.                                                                                            |                                                       |                   |                             |
| 9.                                                                                            | Known hypersensitivity to deferoxamine or any of its  |                   |                             |
| components                                                                                    |                                                       |                   |                             |
| *All subject files must include supporting documentation to confirm subject eligibility.  The |                                                       |                   |                             |  
method of confirmation can include, but is not limited to, laboratory test results, radiology test results, subject self-report, and medical record review.
pilot study evaluating panitumumab-irdye800 and
iv. statement of eligibility

By signing this form of this trial I verify that this subject is [       eligible /
the study.  This study is approved by the Stanford Cancer Institute Scientific Review Committee, the Stanford IRB, and has finalized financial and contractual agreements as required by Stanford School of Medicine's Research Management Group.  
Treating Physician Signature:
Date:  
| Printed Name:                 |       |
|-------------------------------|-------|
| Secondary Reviewer Signature: | Date: |
| Printed Name:                 |       |
| Study Coordinator Signature:  | Date: |
| Printed Name:                 |       |
pilot study evaluating panitumumab-irdye800 and
appendix b optical imaging modalities

All of the non-significant risk (NSR) devices listed below, in the determination of the Investigator, meet the following criteria when used as proposed in this study:
Are not implanted Do not support or sustain human life Are not of substantial importance for diagnosis, curing, mitigating or treating disease; or otherwise preventing impairment of human health Do not present any other potential for serious risk to the health, safety or welfare of subjects  
| Serial No. of submission                                                                                                                    |                             |                             |        |        |        |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------|--------|--------|--------|
| Device name                                                                                                                                 | Manufacturer                | Commercially available?     | 510(k) | NSR?   | to     |
| Intraoperative near-infrared fluorescence imaging, in vivo Spy-Phi– and/or PINPOINT - R9000 (Handheld/Endoscopic)                           | Novadaq Inc.                | Yes (modified light source) | No     | Yes    | SN0000 |
| Explorer Air                                                                                                                                | SurgVision                  | Yes (modified light source) | No     | Yes    | SN0000 |
| PDE-NEO II and/or FIGS                                                                                                                      | Hamamatsu  Photonics KK.    | Yes                         | Yes    | N/A    | SN0000 |
| IMAGE1 S RUBINA System*                                                                                                                     | Karl Storz                  | Yes                         | N/A    | Yes    | SN0017 |
| Intraoperative near-infrared fluorescence imaging, ex vivo (back table) Spy-Phi– and/or PINPOINT - R9000 (Handheld/Endoscopic) Novadaq Inc. | Yes (modified light source) | No                          | Yes    | SN0000 |        |
| Explorer Air                                                                                                                                | SurgVision                  | Yes (modified light source) | No     | Yes    | SN0000 |
| IGP ELVIS v4                                                                                                                                | LI-COR Biosciences          | No                          | No     | Yes    | SN0000 |
| PDE-NEO II and/or FIGS                                                                                                                      | Hamamatsu  Photonics KK.    | Yes                         | Yes    | N/A    | SN0000 |
| IMAGE1 S RUBINA System*                                                                                                                     | Karl Storz                  | Yes                         | N/A    | Yes    | SN0017 |  
| Serial No. of submission                                                               |                         |                         |        |      |    |
|----------------------------------------------------------------------------------------|-------------------------|-------------------------|--------|------|----|
| Device name                                                                            | Manufacturer            | Commercially available? | 510(k) | NSR? | to |
| Laboratory near-infrared fluorescence imaging, ex vivo Pearl Triology                  | LI-COR Biosciences      | Yes                     |        |      |    |
| Odyssey CLx                                                                            | LI-COR Biosciences      | Yes                     |        |      |    |
| IGP ELVIS v4                                                                           | LI-COR Biosciences      | No                      |        |      |    |
| Leica fluorescence microscope                                                          | Leica                   | Yes                     |        |      |    |
| Vevo LAZR-X                                                                            | Visualsonics            | Yes                     |        |      |    |
| Firefly stand-alone device                                                             | Intuitive Surgical Inc. | Yes                     |        |      |    |
| * Please refer to Appendix D for IMAGE1 S RUBINA System Karl Storz Components Overview |                         |                         |        |      |    |
pilot study evaluating panitumumab-irdye800 and
appendix c imaging modalities for

All of the non-significant risk (NSR) devices listed below, in the determination of the Investigator, meet the following criteria when used as proposed in this study:
Are not implanted Do not support or sustain human life Are not of substantial importance for diagnosis, curing, mitigating or treating disease; or otherwise preventing impairment of human health Do not present any other potential for serious risk to the health, safety or welfare of subjects  
| Commercially                                             | Serial No. of submission         |      |                        |     |     |
|----------------------------------------------------------|----------------------------------|------|------------------------|-----|-----|
| available?                                               | 510(k)                           | NSR? | to                     |     |     |
| Device name                                              | Manufacturer                     |      |                        |     |     |
| Intraoperative imaging, in vivo Beta probe + Node Seeker | IntraMedical Imaging             | Yes  | Exempt, class I device | No  | N/A |
| Neoprobe                                                 | Leica Biosystems                 | Yes  | Yes, K971167           | No  | N/A |
| Crystal probe                                            | Crystal Photonics                | Yes  | Exempt, class I device | No  | N/A |
| Ex vivo imaging (back table) Beta probe + Node Seeker    | IntraMedical Imaging             | Yes  | Exempt, class I device | No  | N/A |
| Neoprobe                                                 | Leica Biosystems                 | Yes  | Yes, K971167           | No  | N/A |
| Crystal probe                                            | Crystal Photonics                | Yes  | Exempt, class I device | No  | N/A |
| Beta camera                                              | IntraMedical Imaging             | No   | Not yet applied for    | N/A | N/A |
| Laboratory imaging  Beta camera                          | IntraMedical Imaging             | No   |                        |     |     |
| Cherenkov imager (LightPath)                             | LightPoint Medical               | Yes  |                        |     |     |
| 1 mm resolution mobile PET scanner                       | Dr Craig Levin (in-house design) | No   |                        |     |     |  
| APPENDIX D: IMAGE1 S RUBINA System Karl Storz Components Overview   |                                                                                    |          |              |              |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------|----------|--------------|--------------|
| Material                                                            | Description                                                                        | Quantity | CE-certified | FDA-approved |
| TM340                                                               | 32" 4K Monitor                                                                     | 1        | X            | X            |
| TC201                                                               | IMAGE1 S CONNECT II, connect module                                                | 1        | X            | X            |
| TC304                                                               | IMAGE1 S 4U-LINK, link module                                                      | 1        | X            | X            |
| TL400                                                               | Cold Light Fountain Power LED Rubina                                               | 1        | X            | X            |
| TH121                                                               | IMAGE1 S 4U RUBINA, OPAL1 NIR/ICG, two-chip 4K UHD camera head                     | 1        | X            | X            |
| 495NCSC                                                             | Fiber Optic Light Cable                                                            | 2        | X            | X            |
| 26003ACA                                                            | HOPKINS Straight Forward Telescope 0°, enlarged view, diameter 10 mm, length 31 cm | 1        | X            | X            |
| 8711AGA                                                             | HOPKINS Straight Forward Telescope 0°, NIR/ICG, ø 10mm, 20cm                       | 1        | X            | X            |
| 8710AGA                                                             | HOPKINS Straight Forward Telescope 0°, NIR/ICG, diameter 5.8 mm, length 20 cm      | 1        | X            | X            |
| 28272 CN/UGK/HC                                                     | Components for mechanical holding arm                                              | 1        | X            | X            |
| 28172 HM/HR                                                         | Components for mechanical holding arm                                              | 1        | X            | X            |
| 28164AC                                                             | HOPKINS Forward Telescope 0°, enlarged view, diameter 4 mm, length 18 cm           | 1        | X            | X            |
| 28614BC                                                             | HOPKINS Forward Telescope 30°, enlarged view, diameter 4 mm, length 18 cm          | 1        | X            | X            |
| 28614FC                                                             | HOPKINS Forward Telescope 45°, enlarged view, diameter 4 mm, length 18 cm          | 1        | X            | X            |
| 20916025 AGA                                                        | VITOM II NIR/ICG Telescope 0°                                                      | 1        | X            | X            |
| 20100032                                                            | Fluorescein Blue Filter System, for fluorescence diagnosis                         | 1        | X            | X            |
| 20100033                                                            | Fluorescein Barrier Filter                                                         | 1        | X            | X            |