NCT03085147Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 15 Mar 2017
- Start date
- 15 Mar 2017
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT03085147
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 23
- From 15 Mar 2017 to the primary completion date, 31 Jul 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Suffolk - Commack (Consent Only) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester (Consent only) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth (Consent Only) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen (Consent Only) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Nassau (Consent Only) Coordinator of this site? Confirm its status | Rockville Centre | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.