CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Panitumumab-IRDye800 +12 moredrug
Likely dose
Panitumumab-IRDye800 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03733210
NCT03733210Phase 1Completed
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Pilot Study Evaluating Panitumumab-IRDye800 and 89Zr-Panitumumab for Dual-Modality Imaging for Nodal Staging in Head and Neck Cancer

Andrei Iagaru·interventional·Posted Nov 7, 2018·Updated May 19, 2023

In Brief

A Phase 1 clinical trial evaluating Panitumumab-IRDye800, 89-Zirconium (Zr-89) Panitumumab, and 11 other interventions for Squamous Cell Carcinoma of the Head and Neck and Carcinoma of the Head and Neck. Completed, enrolled 14 participants across 1 site.

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Head and Neck, Carcinoma of the Head and Neck
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 7, 2018
Enrollment StartJan 7, 2019
Primary CompletionDec 11, 2020
Study CompletionAug 9, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.7 years ago

Interventions

Panitumumab-IRDye800drug

30 mg administered intravenously (IV)

89-Zirconium (Zr-89) Panitumumabdrug

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

Pinpoint IR IR9000 fluorescence imaging system (FIS)device

Handheld fluorescence-imaging endoscope manufactured by Novadaq

SPY-PHI IR9000 fluorescence imaging system (FIS)device

Handheld fluorescence-imaging endoscope manufactured by Novadaq

Explorer Air cameradevice

Fluorescence camera manufactured by SurgVision

PDE-NEO II cameradevice

Medical infrared camera manufactured by Hamamatsu Photonics KK

FIS-00 fluorescence imaging system (FIS)device

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

Da Vinci Firefly Imaging Systemdevice

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

IGP-ELVIS-v4 Macroscopic Specimen Imagerdevice

Macroscopic specimen imager manufactured by LI-COR Biosciences

Vevo 3100 LAZR-Xdevice

Photoacoustic ultrasound imaging system manufactured by VisualSonics

Pearl Triology Imaging Systemdevice

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

Odyssey CLx Imaging Systemdevice

Infrared fluorescent-imaging system manufactured by LI-COR Biosciences

Leica fluorescence microscopedevice

Fluorescence microscope manufactured by Leica