drugset / Trial / NCT01987375

Cetuximab IRDye800 Study as an Optical Imaging Agent to Detect Cancer During Surgical Procedures

NCT01987375

Phase 1 Terminated 1 enrolled Eben Rosenthal
NaSingle-groupOpen-labelDiagnostic

Summary

This study is an open label, single institution, Phase 1 dose-escalation study to determine the safety profile of cetuximab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Participants will be given a dose of an approved head and neck cancer drug (Cetuximab) along with an investigational study drug called Cetuximab-IRDye800. Cetuximab-IRDye800 is a drug that is given prior to surgery that attaches to cancer cells and appears to make them visible to the doctor when he uses a special camera during the operation. The investigators are evaluating whether or not the use of the study drug along with the special camera will better identify the cancer while patients are in the operating room.

Timeline

Start
2015-11
Primary completion
2017-04-19
Completion
2017-04-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab-IRDye800 Monoclonal antibody 50 mg Intravenous

Indications