Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors
Condition: Head and Neck Cancer; Lung Cancer; Liver Cancer; Rectal Cancer; Cervical Cancer
MeSH terms: Rectal Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms; Liver Neoplasms; Hypoxia
Intervention: [F 18]HX4
Intervention description: 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
Intervention MeSH terms: Imidazole
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: [F 18]HX4; HX4; Hypoxia; Head/Neck Cancer; Lung Cancer; Liver Cancer; Rectal Cancer; Cervical Cancer; HIF1 alpha; CAIX

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.
    

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