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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Oral Squamous Cell Carcinoma (OSCC) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olaparib

Drug

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.

Other names: PARPi

Primary outcomes

escalating levels of toxicity (CTCAE v 4.0)

Time frame: 1 year

toxicity data relevant to study interventions (CTCAE v 4.0)

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2026
Study completion: 2026
First posted: Mar 21, 2017
Registry last updated: Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting