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

Summary

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.

Conditions

• Head and Neck Cancer
• Lung Cancer
• Liver Cancer
• Rectal Cancer
• Cervical Cancer

Interventions

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

Sponsors & Collaborators

• Siemens Molecular Imaging

  lead INDUSTRY

Principal Investigators

• Jacqueline Brunetti, MD · Holy Name Hospital

• Orhan Nalcioglu, PhD · University of California Irvine Medical Center, Orange, CA

• Alan Waxman, MD · Cedars-Sinai Medical Center, Los Angeles, CA

• Kyung-Han Lee, MD · Sungkyunkwan University School of Medicine, Samsung Medical Center, Gangnam-gu, Seoul, Korea

• Dae-Hyuk Moon, MD · University of Ulsan College of Medicine, Asan Medical Center, Songpa-gu, Seoul, Korea

• Scott Dessain, MD, PhD · Lankenau Institute for Medical Research, Wynnewood, PA and Bryn Mawr Hospital Outpatient Imaging Center, Bryn Mawr, PA

• Rathan Subamaniam, MD · Boston Medical Center, Boston, MA

• Shyam Srinivas, MD, PhD · Cleveland Clinic, Cleveland, OH

• Nasrin Ghesani, MD · University of Medicine and Dentistry of New Jersey, NJMS-UH/UMDNJ Cancer Center, and University Heights Advanced Imaging Center, Newark, NJ

• John M Buatti, MD · University of Iowa Hospitals and Clinics, Carver College of Medicine, and Holden Comprehensive Cancer Center,Iowa City, Iowa

Study Design

Allocation

NA

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2011-05-31

Completion

2012-02-29