Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Squamous Cell Carcinoma (OSCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olaparib | Drug | Olaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluorescent PARPi Binding Imaging Agent PARPi-FL
- description
- In the phase I of the study, increasing concentrations of PARPi-FL will be used in up to 12 patients with OSCC to determine concentration that results in the highest contrast between tumor and normal mucosa. Dose escalation will be performed in groups of three patients until image contrast decreases, side effects are noted or the concentration of PARPi-FL exceeds 1μM. Imaging will be performed in the Department of Surgery during a presurgical visit including clinical examination of the oral cavity. In the phase II part of the study the concentration of PARPi-FL determined in phase I will be used to image 18 patients with OSCC on the day of surgery. Imaging findings will be correlated with histopathologic findings in the surgically resected specimens.
- interventionNames
- Drug: Olaparib
Primary outcomes (1)
- measure
- escalating levels of toxicity (CTCAE v 4.0)
- timeFrame
- 1 year
- description
- toxicity data relevant to study interventions (CTCAE v 4.0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDemetrio de Souza Franca P, Kossatz S, Brand C, Karassawa Zanoni D, Roberts S, Guru N, Adilbay D, Mauguen A, Valero Mayor C, Weber WA, Schoder H, Ghossein RA, Ganly I, Patel SG, Reiner T. A phase I study of a PARP1-targeted topical fluorophore for the detection of oral cancer. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3618-3630. doi: 10.1007/s00259-021-05372-6. Epub 2021 May 5. PMID 33954826