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Panitumumab IRDye800 Optical Imaging Study

NCT02415881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-09-24

No results posted yet for this study

Summary

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Conditions

Interventions

DRUG

Panitumumab IRDye 800

Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery

DEVICE

da Vinci Firefly

Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology)

DEVICE

IMAGE1 + ICG Hopkins telescope and/or VITOM

IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery.

Sponsors & Collaborators

  • Eben Rosenthal

    lead OTHER

Principal Investigators

  • Eben L Rosenthal, MD · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-11-23
Completion
2021-09-21
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02415881 on ClinicalTrials.gov