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

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03085147

Patient View

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

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.

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