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

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 \[positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations\].

Conditions

• Squamous Cell Carcinoma of the Head and Neck
• Carcinoma of the Head and Neck

Interventions

DRUG

Panitumumab-IRDye800

30 mg administered intravenously (IV)

DRUG

89-Zirconium (Zr-89) Panitumumab

0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)

DEVICE

Pinpoint IR IR9000 fluorescence imaging system (FIS)

Handheld fluorescence-imaging endoscope manufactured by Novadaq

DEVICE

SPY-PHI IR9000 fluorescence 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

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Andrei Iagaru

  lead OTHER

Principal Investigators

• Andrei Iagaru, MD · Stanford Medicine at Stanford University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-07

Primary Completion

2020-12-11

Completion

2021-08-09

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations