Fluorine F-18 PARP Inhibitor PET/CT in Diagnosing Patients with Head and Neck Squamous Cell Cancer

PRIMARY OBJECTIVES:

I. To evaluate the safety of fluorine-18 poly adenosine diphosphate (ADP)-ribose polymerase inhibitor ([18F]-PARPi) (fluorine F-18 PARP inhibitor) for imaging head and neck squamous cell carcinomas. (Part I, Completed)

II. To determine the biodistribution and radiation dosimetry of [18F]-PARPi. (Part I, Completed)

III. To obtain data on tumor uptake of [18F]-PARPi and its kinetics. (Part I, Completed)

IV. To evaluate the sensitivity and specificity of [18F]-PARPi for primary head and neck squamous cell carcinomas. (Part II)

V. To evaluate the sensitivity and specificity of [18F]-PARPi for neck metastasis. (Part II)

VI. To preliminarily compare the sensitivity and specificity of [18F]-PARPi against the standard of care [18F]-FDG. (Part II)

EXPLORATORY OBJECTIVES:

I. To perform correlative studies comparing tumor uptake of [18F]-PARPi PET/CT with poly ADP-ribose polymerase type 1/2 (PARP1/2) expression in resected tumor tissue whenever tissue is available. (Part I)

II. To describe the uptake of [18F]-PARPi by lymph nodes that are enlarged on standard of care imaging, but show no metastatic disease on histology whenever tissue is available. (Part I)

III. To perform correlative studies comparing tumor uptake of [18F]-PARPi PET/CT with PARP1/2 expression in resected tumor tissue whenever tissue is available. (Part I and II)

OUTLINE:

PART 1: Patients receive fluorine F-18 PARP inhibitor intravenously (IV) over 5-10 minutes and undergo initial PET/CT scan over 30 minutes. Patients also undergo 2 additional PET/CT scans at 60 and 120 minutes post-injection in the absence of disease progression or unacceptable toxicity.

PART 2: Patients receive fluorine F-18 PARP inhibitor IV over 5-10 minutes and undergo PET/CT scan 120 minutes post-injection in the absence of disease progression or unacceptable toxicity.

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