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

Last updated: February 10, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Carcinoma

Lung Cancer

Head And Neck Cancer

Treatment

Olaparib

Clinical Study ID

NCT03085147
15-336
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is ≥ 18 years old

  • Histologically or cytologically proven squamous cell carcinoma of the oral cavity orpharynx (OSCC)

  • Scheduled to undergo surgery at MSK

  • Any tumor stage, any N, M0

  • ECOG performance status 0 or 1

Exclusion

Exclusion Criteria:

  • Any surgical therapy in the area of the oral cavity or pharynx within the last 2weeks

  • Prior or ongoing treatment with a PARP1 inhibitor

  • Known hypersensitivity to Olaparib

  • Known hypersensitivity to PEG Eligibility criteria will be assessed by anexperienced oral surgeon, typically the Co-PI of the study.

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: Olaparib
Phase: 1/2
Study Start date:
March 15, 2017
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (Consent Only)

    Basking Ridge, New Jersey 07920
    United States

    Site Not Available

  • Memorial Sloan Kettering Monmouth (Consent only)

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • Memorial Sloan Kettering Bergen (Consent only)

    Montvale, New Jersey 07645
    United States

    Site Not Available

  • Memorial Sloan Kettering Suffolk-Commack (Consent only)

    Commack, New York 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering Westchester (Consent Only)

    Harrison, New York 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (Consent only)

    Rockville Centre, New York 11553
    United States

    Site Not Available

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