An Exploratory, Open Label, Single Center Study of [F-18]HX4

Summary

\[F-18\]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.

Conditions

• Head and Neck Cancer

Interventions

DRUG

20 mCi dose for a 50 kg individual of [F-18]HX4

All subjects, normal volunteers and cancer subjects will receive HX4 administered through a previously placed suitably sized angiocatheter or a butterfly needle. Prior to injection, qualified site personnel will assay the dose in the dose calibrator and document the activity of the dose and time of assay. After injection, the line will be flushed with saline (approximately 10 mL).

Sponsors & Collaborators

• Siemens Molecular Imaging

  lead INDUSTRY

Principal Investigators

• Michael Yu, MD · Fox Chase Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2009-01-31

Completion

2009-01-31

Countries

• United States

Study Locations