PARPi-FL and Fluorescence Imaging in Detecting Cancer in Patients with Oral Cancer

PRIMARY OBJECTIVES:

I. To evaluate the safety of PARPi-FL for imaging of tumors in the oral cavity and pharynx. (Phase I)

II. To determine the concentration of PARPi-FL that results in the highest contrast between tumor and normal mucosa. (Phase I)

III. To obtain preliminary data on the biochemical specificity of PARPi-FL (specific tracer accumulation on the nuclei of neoplastic cells). (Phase II)

IV. To obtain preliminary data on the statistical sensitivity and specificity of PARPi-FL imaging to detect oral squamous cell carcinoma (OSCC) with blinded data. (Phase II)

V. To obtain preliminary data on the ability of PARPi-FL to delineate local extent of tumor during surgery. (Phase II)

EXPLORATORY OBJECTIVES:

I. To evaluate the ability of the point scanning confocal microscope to visualize PARPi-FL expression in tumor cell nuclei.

II. If possible, on the first 20 patients (the 12 on phase I and the first 8 on phase II), images will also be compared to the corresponding pathology (standard of care hematoxylin/eosin [H&E] staining).

OUTLINE: This is a phase I, dose escalation study followed by a phase II study.

Patients gargle with PARPi-FL over 1-2 minutes then spit it out and gargle with a clearing solution (the solvent used for PARPi-FL and/or 1% acetic acid and/or water). Patients then undergo fluorescence imaging over 10-30 minutes. Patients in the phase II study also undergo biopsy of the tumor during surgery.

After completion of study, patients are followed up at 1-3 days.