Clinical Trial-A Dye for the Detection of Cancer of the Tongue and Mouth- Oral Cancer

The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.

Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open label, investigator initiated single arm phase I/II study. The concentration for imaging OSCC is defined in Phase I. Phase II will then use this concentration to obtain preliminary data on the sensivity of PARPi-FL to detect and delinate OSCC.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas
Actual Study Start Date  : March 15, 2017
Estimated Primary Completion Date  : March 2019
Estimated Study Completion Date  : March 2019
Contact: Heiko Schoder, MD 212-639-2079
Contact: Thomas Reiner, PhD 646-888-2008
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Heiko Schoder, MD    212-639-2079
Contact: Thomas Reiner, PhD    646-888-2008
Principal Investigator: Heiko Schoder, MD Identifier: NCT03085147
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