A Dye for the Detection of Cancer of the Tongue and Mouth
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT03085147
This study evaluates the safety and optimal dose of PARPi-FL dye for detecting oral and tongue cancer. Eligible participants are adults with confirmed OSCC, scheduled for surgery at MSK, and have an ECOG status of 0 or 1. Participants will gargle PARPi-FL, followed by a cleaning solution, and undergo fluorescence imaging to assess tumor detection efficacy.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility Criteria
Inclusion Criteria
- Patient is ≥ 18 years old
- Histologically or cytologically proven squamous cell carcinoma of the oral cavity or pharynx (OSCC)
- Scheduled to undergo surgery at MSK
- Any tumor stage, any N, M0
- ECOG performance status 0 or 1
Exclusion Criteria
- Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks
- Prior or ongoing treatment with a PARP1 inhibitor
- Known hypersensitivity to Olaparib
- Known hypersensitivity to PEG Eligibility criteria will be assessed by an experienced oral surgeon, typically the Co-PI of the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Consent only) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Consent only) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Consent only) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Consent Only) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Consent only) | 11553 | Rockville Centre | New York |
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