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ACTIVE NOT RECRUITING
NCT03085147
PHASE1/PHASE2

A Dye for the Detection of Cancer of the Tongue and Mouth

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2017-03-15

Completion Date

2026-07

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DRUG

Olaparib

For PARRi-FL, imaging patients will first gargle a solution of PARRi-FL for 1 min, then spit out this solution and gargle with a cleaning solution (the solvent used for PARRi-FL) for 1 min. Then fluorescence imaging of the oral cavity and pharynx will be performed with an endoscope. The intensity and extent of the fluorescence signal will be recorded by one of the investigators for the tumor and adjacent normal mucosa.

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Consent only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Consent only)

Rockville Centre, New York, United States