Know Cancer

forgot password

A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) to Detect Hypoxia in Tumors

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer, Lung Cancer, Liver Cancer, Rectal Cancer, Cervical Cancer

Thank you

Trial Information

A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) to Detect Hypoxia in Tumors

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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To evaluate two sequential pre-treatment [F 18]HX4 PET scans (recommended to be within 48 hours of each other) in order to assess reproducibility and reliability of [F 18]HX4 PET imaging for measuring hypoxia in tumors

Outcome Time Frame:

(3) or (4) visits over a period of approximately 6 weeks

Safety Issue:


Principal Investigator

Jacqueline Brunetti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Holy Name Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2010

Completion Date:

February 2012

Related Keywords:

  • Head and Neck Cancer
  • Lung Cancer
  • Liver Cancer
  • Rectal Cancer
  • Cervical Cancer
  • [F 18]HX4
  • HX4
  • Hypoxia
  • Head/Neck Cancer
  • Lung Cancer
  • Liver Cancer
  • Rectal Cancer
  • Cervical Cancer
  • HIF1 alpha
  • CAIX
  • Rectal Neoplasms
  • Uterine Cervical Neoplasms
  • Head and Neck Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Anoxia