Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors

A Pilot Phase II Study

The primary objectives for this study are:

- To test the reproducibility of [F-18] HX-4 uptake in tumors by imaging the same patient
on sequential days in a test-retest protocol

- To test and confirm the relationship between hypoxia in tumors measured by hypoxia
related biomarkers (HIF1α and CA-IX) with immunohistochemistry (IHC) and regional [F-18
HX-4] uptake in tumors with PET/CT.

The secondary objectives for this study are:

- To continue safety evaluation by the collection of safety data from all patients

- To establish the threshold for hypoxia uptake in [F- 18]HX4 PET imaging

- To collect data to test [F-18]HX4 PET imaging as a predictor of response in a subgroup
of patients receiving treatment

- To gain experience with [F-18]HX4 PET/CT in order to improve the study design to
conduct future studies

Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy
study

Procedures: Informed consent, collection of demographic information, medical history, blood
labs, physical examination, vital signs, ECGs, two or three sets of [F-18]HX4 dosing and
imaging scans including two pretreatment, and one mid-treatment if [F-18]HX4
tumor/background ratio ≥ 1.3 from pre-treatment scans, one pre-treatment [F-18]FDG, one
mid-treatment if [F- 18]HX4 tumor/background ratio ≥1.3 from pre-treatment scans,
concomitant medication collection, adverse event monitoring, and assessment of tumor
response to treatment

Patients: Approximately forty (40) patients who have diagnosis confirmed by
histopathological examination of tumor tissue from head/neck, lung, liver, rectal or
cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy. This
allows for approximately 30 evaluable patients to complete this study at approximately six
sites.