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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Siemens Molecular Imaging
• Treatments: Imidazole

Criteria

Inclusion Criteria:

• Patient is >18 years and male or female of any race / ethnicity

• Patient or patient's legally acceptable representative provides written informed consent and is willing to comply with protocol procedures

• Patient must have histopathologically confirmed head/neck, lung, liver, rectal or cervical cancer with tumor size ≥ 3cm

• Patient has tumor tissue samples available before treatment for future immunohistochemistry biomarker tests (HIF1alpha and CA-IX)

• Patient is scheduled to have or already had a clinical [F 18]FDG PET/CT scan recommended to be within 14 days of the first pre-treatment [F 18]HX4 PET/CT scan and have no treatment intervention in between these two scans

• Patient is scheduled or is intended to be scheduled to receive chemotherapy, radiation or chemoradiotherapy treatment(s) after the pre-treatment [F 18]HX4 PET/CT and [F 18]FDG PET/CT scans for his/her cancer care

• Patient must have hepatic and renal functions as defined by laboratory results within the following ranges:

• Total bilirubin within 2 times institutional upper limit of normal

• AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional upper limits of normal

• Serum creatinine ≤ 2.5 times institutional limit of normal

• BUN within 2 times institutional upper limit of normal

Exclusion Criteria:

• Patient is not capable of complying with study procedures

• Female patient is pregnant or nursing

o Exclude the possibility of pregnancy by one of the following:

• Confirming in medical history that the patient is post-menopausal for a minimum of one year, or surgically sterile

• Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant

• Confirming a negative urine dipstick test taken the morning of but before receiving [F 18]HX4

• Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period

• Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data