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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075399
|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|