Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Fluorodeoxyglucose F18

Panitumumab

Fluorophosphate

Antineoplastic Agents, Immunological

Participants whose lymph nodes are negative for cancer

Participants whose lymph nodes are positive for cancer.

Panitumumab-IRDye800

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

89-Zirconium (Zr-89) Panitumumab

Handheld fluorescence-imaging endoscope manufactured by Novadaq

Pinpoint IR IR9000 fluorescence imaging system (FIS)

SPY-PHI IR9000 fluorescence imaging system (FIS)

Fluorescence camera manufactured by SurgVision

Explorer Air camera

Medical infrared camera manufactured by Hamamatsu Photonics KK

PDE-NEO II camera

Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK

FIS-00 fluorescence imaging system (FIS)

Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc

Da Vinci Firefly Imaging System

Macroscopic specimen imager manufactured by LI-COR Biosciences

IGP-ELVIS-v4 Macroscopic Specimen Imager

Photoacoustic ultrasound imaging system manufactured by VisualSonics

Vevo 3100 LAZR-X

Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences

Pearl Triology Imaging System

Infrared fluorescent-imaging system manufactured by LI-COR Biosciences

Odyssey CLx Imaging System

Fluorescence microscope manufactured by Leica

Leica fluorescence microscope

Andrei Iagaru, MD

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

For patients with head and neck cancer, detection of malignant cells within nearby lymph nodes (LNs) is an important measure of the extent and severity of the cancer. LNs are a key immunologic organ involved in overall immune surveillance. Historically, LN or LNs were harvested before the surgery of curative intent, evaluated pathologically, and then tumor status of the harvested LNs were utilized to inform the individual surgical plan. These LNs became known as "sentinel lymph nodes." In recent years, techniques have been developed to utilize peritumoral injection (around the tumor) of tumor labels that could identify tumor in the LNs without biopsy, ie, only LNs that were tumor-positive would be removed. However, in some patients, this technique could be limited by the location of the primary cancer. Effective and sensitive systemically-administered labels would be a significant advancement. The systemically-administered label 18F-fluorodeoxyglucose (18F-FDG), detected by positron emission tomography / computed tomography (PET/CT) and/or PET / magnetic imaging resonance (PET/MRI) radiologic scans and representing current regular medical care, has provided improvement in detection of cancer-positive LNs. However, further enhancements may be possible.

Participants with squamous cell carcinoma of the head and neck (SCCHN) and scheduled to undergo regular medical care surgery with curative intent, were assigned to 2 study groups on the basis of whether regular medical care scans using 18F-FDG PET/CT or PET/MRI had indicated that cancer was suspected in the lymph nodes (LN+ or cN+), or without suspected cancer in the lymph nodes (LN- or cN0). Following the 18F-FDG, and prior to surgery, 89Zr-panitumumab was systemically administered by intravenous infusion, and a PET-CT imaging scan was conducted. 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. Regular medical care surgical excision of the tumor and adjacent LN was conducted on Day 2 to 5. After surgery, patients are followed up at 15 and 30 days.

PRIMARY OBJECTIVES:

I. Determine the sensitivity and specificity of zirconium(89Zr)-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.

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

Pilot Study Evaluating Panitumumab-IRDye800 and 89Zr-Panitumumab for Dual-Modality Imaging for Nodal Staging in Head and Neck Cancer

The value of experimental 89Zr-panitumumab as a radiologic label was assessed as the number of lymph nodes (LNs) that have false-negative results. A false-negative result in this study is one that does not indicate that cancer is present in the lymph node, when histopathologic evaluation confirms the presence of cancer in the lymph nodes. The outcome is reported as the number of false-negative lymph nodes observed after systemic labeling with 89Zr-panitumumab and 18F-FDG, an established agent for this use. The outcome results are numbers without dispersion.

The value of experimental 89Zr-panitumumab as a radiologic label was assessed by determining the positive predictive value (PPV) and the negative predictive value (NPV). PPV is a measure of extent that positive-labeled samples that were actually cancer, expressed as a proportion (ratio) of the number of positive-labeled samples vs samples positive by histopathology (positive label/positive histopathology). NPV is a measure of extent that negative-labeled samples (not positive) that were actually NOT cancer, expressed as a proportion (ratio) of the number of negative-labeled samples vs samples NOT positive by histopathology (negative label/negative histopathology). The closer the proportions are to 1, the better the predictive value. The outcome is reported as the PPV and NPV of 89Zr-panitumumab and 18F-fluorodeoxyglucose (18F-FDG), an established agent for this use. The outcome results are ratios, numbers without dispersion.

The ability of 89Zr-panitumumab and 18F-fluorodeoxyglucose (18F-FDG) to detect tumor in lymph nodes were assessed on the basis of radiologic scans and histopathologic evaluation of excised lymph nodes (LNs). The histopathologic assessment was considered the definitive, regular medical care, assessment. The outcome is reported by study group as the number of LNs that were identified as tumor-positive by 18F-FDG- and 89Zr-panitumumab, stratified by the tumor-positivity as assessed by histopathology, and expressed as the number of LNs that were tumor-positive by both, negative for both, or positive for one and not the other. Results are also provided by study group for the number of LNs that tumor-positive by both 18F-FDG- and 89Zr-panitumumab, negative for both, or positive for one and not the other. The outcome is numbers without dispersion

The value of 89Zr-panitumumab and panitumumab-IRDye800 as a label for cancer cells (radiologic or fluorescent, respectively), was assessed by the sensitivity and specificity for the detection of tumor cells in lymph nodes near the tumor. 18F-fluorodeoxyglucose (18F-FDG), an established agent for this use, was also assessed. Sensitivity was assessed as the "true positive rate" of paired measurements, expressed as the proportion (ratio) of the number of specimens positive by histopathology also positive by the test method (test:histopathology). Specificity is the "true negative rate", the proportion of the number of specimens negative by histopathology also negative by the test method. The closer the proportions are to 1, the greater the sensitivity or specificity. The outcome is reported as the sensitivity and specificity of 89Zr-panitumumab, panitumumab-IRDye800, and 18F-fluorodeoxyglucose (18F-FDG). The outcome results are ratios, a number without dispersion.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Andrei Iagaru

Professor of Radiology (Nuclear Medicine)

Participants whose lymph nodes are negative for cancer

Panitumumab-IRDye800: 30 mg administered intravenously (IV)

Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)

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

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

Explorer Air camera: Fluorescence camera manufactured by SurgVision

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

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

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

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

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

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

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

Leica fluorescence microscope: Fluorescence microscope manufactured by Leica

Tumor-negative Lymph Nodes (by 18F-FDG Scan)

Participants whose lymph nodes are positive for cancer.

Panitumumab-IRDye800: 30 mg administered intravenously (IV)

Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)

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

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

Explorer Air camera: Fluorescence camera manufactured by SurgVision

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

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

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

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

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

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

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

Leica fluorescence microscope: Fluorescence microscope manufactured by Leica

Tumor-positive Lymph Nodes (by 18F-FDG Scan)

Participants whose lymph nodes are negative for cancer

Panitumumab-IRDye800: 30 mg administered intravenously (IV)

Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)

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

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

Explorer Air camera: Fluorescence camera manufactured by SurgVision

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

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

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

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

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

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

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

Leica fluorescence microscope: Fluorescence microscope manufactured by Leica

Participants whose lymph nodes are positive for cancer.

Panitumumab-IRDye800: 30 mg administered intravenously (IV)

Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)

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

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

Explorer Air camera: Fluorescence camera manufactured by SurgVision

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

FIS-00 fluorescence imaging system (FIS): Fluorescenc3-imaging system (FIS) manufactured by Hamamatsu Photonics KK

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

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

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

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

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

Leica fluorescence microscope: Fluorescence microscope manufactured by Leica

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Yu-Jin Lee, MD, MS

89Zr-panitumumab-positive & pathology-positive

89Zr-panitumumab-positive & pathology-negative

89Zr-panitumumab-negative & pathology-positive

89Zr-panitumumab-negative & pathology-negative

18F-FDG-positive & pathology-positive

18F-FDG-positive & pathology-negative

18F-FDG-negative & pathology-positive

18F-FDG-negative & pathology-negative

89Zr-panitumumab-positive & 18F-FDG-positive

89Zr-panitumumab-positive & 18F-FDG-negative

89Zr-panitumumab-negative & 18F-FDG-positive

89Zr-panitumumab-negative & 18F-FDG-negative

Some participants did not have lymph nodes collected, or the collected lymph nodes were not evaluable. Some lymph nodes were not evaluable by all methodologies.

Detection of Tumor in Lymph Nodes by 18F-FDG and 89Zr-panitumumab Labeling

89Zr-panitumumab Sensitivity

89Zr-panitumumab Specificity

Panitumumab-IRDye800 Sensitivity

Panitumumab-IRDye800 Specificity Panitumumab-IRDye800 Specificity

18F-FDG Sensitivity

18F-FDG Specificity

Some participants did not have lymph nodes collected, or the collected lymph nodes were not evaluable. Some lymph nodes were not evaluable by all methodologies.Some participants did not have lymph nodes collected, or the collected lymph nodes were not evaluable. Some lymph nodes were not evaluable by all methodologies.

Sensitivity and Specificity of 89Zr-panitumumab, 18F-FDG, and Panitumumab-IRDye800

89Zr-panitumumab False-negatives

18F-FDG False-negatives

89Zr-panitumumab and 18F-FDG False-negatives

89Zr-panitumumab Positive Predictive Value (PPV)

89Zr-panitumumab Negative Predictive Value (NPV)

18F-FDG Positive Predictive Value (PPV)

18F-FDG Negative Predictive Value (NPV)

Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of 89Zr-panitumumab and 18F-FDG

Participants whose lymph nodes are positive for cancer.

Panitumumab-IRDye800: 30 mg administered intravenously (IV)

Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)

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

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

Explorer Air camera: Fluorescence camera manufactured by SurgVision

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

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

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

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

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

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

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

Leica fluorescence microscope: Fluorescence microscope manufactured by Leica

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer	NCT03733210	Squamous Cell C... Carcinoma of th...	Panitumumab-IRD... 89-Zirconium (Z... Pinpoint IR IR9... SPY-PHI IR9000 ... Explorer Air ca... PDE-NEO II came... FIS-00 fluoresc... Da Vinci Firefl... IGP-ELVIS-v4 Ma... Vevo 3100 LAZR-... Pearl Triology ... Odyssey CLx Ima... Leica fluoresce...	19 Years -	Stanford University
Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer	NCT03733210	Squamous Cell C... Carcinoma of th...	Panitumumab-IRD... 89-Zirconium (Z... Pinpoint IR IR9... SPY-PHI IR9000 ... Explorer Air ca... PDE-NEO II came... FIS-00 fluoresc... Da Vinci Firefl... IGP-ELVIS-v4 Ma... Vevo 3100 LAZR-... Pearl Triology ... Odyssey CLx Ima... Leica fluoresce...	19 Years -	Stanford University

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