An Exploratory, Open Label, Single Center Study of [F-18]HX4 (HX4)
[F-18]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging. This trial is looking at the safety of [F-18]HX4.
The Sponsor is seeking to determine if [F-18]HX4 may serve as a clinically useful hypoxia marker in diagnostic imaging, allowing the rational application of hypoxia related therapies to those patients most likely to benefit from them.
Tumor hypoxia, a situation where tumor cells have been deprived of oxygen, caused cancer cells to become more resistant to the effects of radiotherapy and chemotherapy.
A non-invasive study characterizing tumor hypoxia would facilitate the development of targeted therapies.
The population to be studied consists of a total of ten (10) adult subjects, including, four normal volunteers and six cancer subjects, the latter with a confirmed diagnosis of head and neck cancer, as defined by the protocol eligibility criteria.
The objectives of this exploratory study are to:
- Gain information on bio-distribution of [F-18]HX4, and to evaluate the PET images of [F-18]HX4 for resolution, signal to background ratio for both intermediate levels of oxygenation, and at extreme levels hypoxia
- Use this eIND in order to obtain the necessary information to file an IND application with the FDA. The information collected under this exploratory study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.
- Begin collection of baseline imaging data
- Collect [F-18]HX4 metabolism data
- Gain information to improve study design and the conduct of future trials
This investigation will be conducted as an exploratory, open-label, non-randomized, uncontrolled, single center, safety study.
The trial is expected to begin subject enrollment in early January 2008 and end subject participation in June 2008.
The duration of an individual subject's participation includes a screening visit, followed by participation in the actual study starting with the day of dosing with imaging sessions lasting several hours, concluding with a next day safety follow-up visit.
Individual doses of [F-18]HX4 shall not exceed 20 mCi. The IP will be administered through a previously placed suitably sized angiocatheter or a butterfly needle. Prior to injection, qualified site personnel will assay the dose. After IP administration several PET imaging series will be acquired. Also, in order to assess major organ function and electrolyte levels, a metabolites analysis will be performed for this study from predose to 90 minutes postdose.
In order to determine the quantity of [F-18]HX4 and labeled metabolites excreted by the kidney,urine will be collected and pooled at the designated intervals after administration of the investigational product. This excretion data will provide supportive information for calculating human dosimetry estimates from PET imaging biodistribution data collected in human subjects.
For cancer subjects, a tissue biopsy will have been taken or be scheduled to be performed. The biopsy sample will be examined for hypoxic biomarker(s) using immunohistochemistry methods.
|Head and Neck Cancer||Drug: 20 mCi dose for a 50 kg individual of [F-18]HX4||Early Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Exploratory, Open Label, Single Center Study of [F-18]HX4|
- Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug. [ Time Frame: 24 hours ]
|Study Start Date:||January 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Drug: 20 mCi dose for a 50 kg individual of [F-18]HX4
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606424
|United States, Pennsylvania|
|Michael Yu, MD|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Michael Yu, MD||Fox Chase Cancer Center|