study of [f 18]hx4 positron emission tomography (pet) as a tool to detect hypoxia in tumors

Conditions: Head and Neck Cancer; Lung Cancer; Liver Cancer; Rectal Cancer; Cervical Cancer

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.

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.

Eligibility 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

Keywords: [f 18]hx4 hx4 hypoxia head/neck cancer lung cancer liver cancer rectal cancer cervical cancer hif1 alpha caix