Phase 2
N=50
Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors
Head and Neck Cancer · Lung Cancer · Liver Cancer · Rectal Cancer · Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01075399 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors — 39 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- [F 18]HX4 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Siemens Molecular Imaging
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors |
39 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT01075399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.