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

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03085147

Enrollment

Registered

2017-03-21

Start date

2017-03-15

Completion date

2027-07-01

Last updated

2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Squamous Cell Carcinoma (OSCC)

Keywords

Tongue, Mouth, Fluorescent PARP1 Binding Imaging Agent, PARPi-FL, 15-336

Brief 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.

Interventions

DRUGOlaparib

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

This is an open label, investigator initiated single arm phase I/II study. The concentration for imaging OSCC is defined in Phase I. Phase II will then use this concentration to obtain preliminary data on the sensivity of PARPi-FL to detect and delinate OSCC.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
escalating levels of toxicity (CTCAE v 4.0)	1 year	toxicity data relevant to study interventions (CTCAE v 4.0)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHeiko Schoder, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026