Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors (HX4-200)
This pilot phase II study is designed as a test and retest study to investigate [F 18]HX4 as a reliable non-invasive PET imaging marker for detection of tumor hypoxia regions and to establish a threshold for [F 18]HX4 uptake in the tumor. The study will evaluate the relationship between hypoxia biomarkers (HIF1α and CA-IX) by immunohistochemistry (IHC) and tumor uptake of [F 18]HX4 by PET imaging.
Head and Neck Cancer
Drug: [F 18]HX4
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) to Detect Hypoxia in Tumors|
- Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors [ Time Frame: Time between 1st and 2nd scan was 1 to 6 days ] [ Designated as safety issue: No ]Primary tumor uptake of [F 18]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.
|Study Start Date:||February 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: [F 18]HX4
[F18]HX4, 10 mCi, is administered in a single intravenous bolus injection, followed by a saline flush.
Drug: [F 18]HX4
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, will be imaged under PET/CT with [F 18]HX4
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.
|Principal Investigator:||Jacqueline Brunetti, MD||Holy Name Hospital|
|Principal Investigator:||Orhan Nalcioglu, PhD||University of California Irvine Medical Center, Orange, CA|
|Principal Investigator:||Alan Waxman, MD||Cedars-Sinai Medical Center, Los Angeles, CA|
|Principal Investigator:||Kyung-Han Lee, MD||Sungkyunkwan University School of Medicine, Samsung Medical Center, Gangnam-gu, Seoul, Korea|
|Principal Investigator:||Dae-Hyuk Moon, MD||University of Ulsan College of Medicine, Asan Medical Center, Songpa-gu, Seoul, Korea|
|Principal Investigator:||Scott Dessain, MD, PhD||Lankenau Institute for Medical Research, Wynnewood, PA and Bryn Mawr Hospital Outpatient Imaging Center, Bryn Mawr, PA|
|Principal Investigator:||Rathan Subamaniam, MD||Boston Medical Center, Boston, MA|
|Principal Investigator:||Shyam Srinivas, MD, PhD||Cleveland Clinic, Cleveland, OH|
|Principal Investigator:||Nasrin Ghesani, MD||University of Medicine and Dentistry of New Jersey, NJMS-UH/UMDNJ Cancer Center, and University Heights Advanced Imaging Center, Newark, NJ|
|Principal Investigator:||John M Buatti, MD||University of Iowa Hospitals and Clinics, Carver College of Medicine, and Holden Comprehensive Cancer Center,Iowa City, Iowa|