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

NCT03733210 | Completed Phase 1 Results DMC FDA Drug FDA Device

• 5 other identifiers: IRB-41878NCI-2018-02270ENT0066P30CA124435R01CA190306
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

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

  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

  up to 5 days

Secondary Outcomes (1)

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

  up to 5 days

Other Outcomes (2)

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

  up to 5 days

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

  up to 5 days

Study Arms (2)

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

EXPERIMENTAL

Participants whose lymph nodes are negative for cancer

Drug: Panitumumab-IRDye800; Drug: 89-Zirconium (Zr-89) Panitumumab; Device: Pinpoint IR IR9000 fluorescence imaging system (FIS); Device: SPY-PHI IR9000 fluorescence 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

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

EXPERIMENTAL

Participants whose lymph nodes are positive for cancer.

Drug: Panitumumab-IRDye800; Drug: 89-Zirconium (Zr-89) Panitumumab; Device: Pinpoint IR IR9000 fluorescence imaging system (FIS); Device: SPY-PHI IR9000 fluorescence 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

Interventions

Panitumumab-IRDye800 DRUG

30 mg administered intravenously (IV)

Also known as: Panitumumab IRDye 800, IRDye800-Panitumumab Conjugate

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

89-Zirconium (Zr-89) Panitumumab DRUG

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

Also known as: 89Zr-panitumumab (SY), 89Zr-labeled Panitumumab (SY), Zr 89-Panitumumab (SY)

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

Pinpoint IR IR9000 fluorescence imaging system (FIS) DEVICE

Handheld fluorescence-imaging endoscope manufactured by Novadaq

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

SPY-PHI IR9000 fluorescence imaging system (FIS) DEVICE

Handheld fluorescence-imaging endoscope manufactured by Novadaq

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

Explorer Air camera DEVICE

Fluorescence camera manufactured by SurgVision

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

PDE-NEO II camera DEVICE

Medical infrared camera manufactured by Hamamatsu Photonics KK

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

FIS-00 fluorescence imaging system (FIS) DEVICE

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

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

Da Vinci Firefly Imaging System DEVICE

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

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

IGP-ELVIS-v4 Macroscopic Specimen Imager DEVICE

Macroscopic specimen imager manufactured by LI-COR Biosciences

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

Vevo 3100 LAZR-X DEVICE

Photoacoustic ultrasound imaging system manufactured by VisualSonics

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

Pearl Triology Imaging System DEVICE

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

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

Odyssey CLx Imaging System DEVICE

Infrared fluorescent-imaging system manufactured by LI-COR Biosciences

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

Leica fluorescence microscope DEVICE

Fluorescence microscope manufactured by Leica

Tumor-negative Lymph Nodes (by 18F-FDG scan); Tumor-positive Lymph Nodes (by 18F-FDG scan)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrei Iagaru: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Yu-Jin Lee, MD, MS
• Organization: Stanford Medicine at Stanford University

yujinlee@stanford.edu

650-725-4711

Study Officials

• Andrei Iagaru, MD

  Stanford Medicine at Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology (Nuclear Medicine)

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: January 7, 2019
• Primary Completion: December 11, 2020
• Study Completion: August 9, 2021
• Last Updated: May 19, 2023
• Results First Posted: May 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)