A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
To evaluate two sequential pre-treatment [F 18]HX4 PET scans (recommended to be within 48 hours of each other) in order to assess reproducibility and reliability of [F 18]HX4 PET imaging for measuring hypoxia in tumors
(3) or (4) visits over a period of approximately 6 weeks
No
Jacqueline Brunetti, MD
Principal Investigator
Holy Name Hospital
United States: Food and Drug Administration
HX4-200
NCT01075399
February 2010
February 2012
Name | Location |
---|