Clinical Trials Directory

Trials / Completed

CompletedNCT03733210

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Andrei Iagaru · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGPanitumumab-IRDye80030 mg administered intravenously (IV)
DRUG89-Zirconium (Zr-89) Panitumumab0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)
DEVICEPinpoint IR IR9000 fluorescence imaging system (FIS)Handheld fluorescence-imaging endoscope manufactured by Novadaq
DEVICESPY-PHI IR9000 fluorescence imaging system (FIS)Handheld fluorescence-imaging endoscope manufactured by Novadaq
DEVICEExplorer Air cameraFluorescence camera manufactured by SurgVision
DEVICEPDE-NEO II cameraMedical infrared camera manufactured by Hamamatsu Photonics KK
DEVICEFIS-00 fluorescence imaging system (FIS)Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK
DEVICEDa Vinci Firefly Imaging SystemFluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc
DEVICEIGP-ELVIS-v4 Macroscopic Specimen ImagerMacroscopic specimen imager manufactured by LI-COR Biosciences
DEVICEVevo 3100 LAZR-XPhotoacoustic ultrasound imaging system manufactured by VisualSonics
DEVICEPearl Triology Imaging SystemNear-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences
DEVICEOdyssey CLx Imaging SystemInfrared fluorescent-imaging system manufactured by LI-COR Biosciences
DEVICELeica fluorescence microscopeFluorescence microscope manufactured by Leica

Timeline

Start date
2019-01-07
Primary completion
2020-12-11
Completion
2021-08-09
First posted
2018-11-07
Last updated
2023-05-19
Results posted
2023-05-19

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03733210. Inclusion in this directory is not an endorsement.