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

Sponsor:	Siemens Molecular Imaging
Information provided by:	Siemens Molecular Imaging
ClinicalTrials.gov Identifier:	NCT00606424

Purpose

[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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: 20 mCi dose for a 50 kg individual of [F-18]HX4	Phase 0

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	An Exploratory, Open Label, Single Center Study of [F-18]HX4

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	January 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal Volunteers

Subject may be male or female and of any race / ethnicity
Subject is > 18 years old at the time of investigational product administration
Subject or subject's legally acceptable representative provides written informed consent
Subject is capable of complying with study procedures
Subject is capable of communicating with study personnel

Cancer Subjects

Subject may be male or female and of any race / ethnicity
Subject is > 18 years old at the time of investigational product administration
Subject or subject's legally acceptable representative provides written informed consent
Subject is capable of complying with study procedures
Subject is capable of communicating with study personnel
Subject must have histologically confirmed stage III, or IV squamous cell carcinoma of the head and neck whose primary origin was from the oral cavity, oropharynx, hypopharynx, or larynx. Carcinoma must be staged using the American Joint Committee on Cancer (AJCC) staging criteria version 6. Adequate tumor must be amenable to biopsy via outpatient methods
According to the Karnofsky Performance Status Scale, the subject has a value of ≥ 60% at time of screening
Subject is scheduled for a clinical FDG PET scan either within 48 hours prior to (with no intervention in between the two scans), or within 48 hours after the investigational [F-18]HX4 PET scan
Subject must have normal organ and renal function as defined:
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) less than or equal to 2.5 x institutional upper limit of normal
- creatinine within normal institutional limits
- BUN within normal institutional limits

Exclusion Criteria:

Normal Volunteers

Subject is younger than 18 years old at the time of investigational product administration
Female subject is pregnant or nursing--Serum pregnancy test must be negative; test must be completed within 24 hours of dosing or female subject must be either surgically sterilized or post- menopausal, defined as at least one year without menses as reported by the subject
Subject is unable to remain still for duration of imaging procedure (~40 mins)
Subject has previously received [F-18]HX4 at any time, or has been involved in an investigative, radioactive research procedure within the past year
Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives.

Cancer Subjects

Subject is younger than 18 years old at the time of investigational product administration
Female subject is pregnant or has a positive serum pregnancy test
Subject is unable to remain still for duration of imaging procedure
Subject has a history of significant renal disease
Subject has previously received [F-18]HX4 at any time, or any other investigational product in the past thirty days.
Subject has been involved in an investigative, radioactive research procedure within the past year
Inadequate tumor sites or volume to allow for biopsy
Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete and good quality data
Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606424

Locations

United States, Pennsylvania
Michael Yu, MD
Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators

Siemens Molecular Imaging

Investigators

Principal Investigator:

Michael Yu, MD

Fox Chase Cancer Center

More Information

No publications provided

Responsible Party:	Siemens Molecular Imaging ( Kathleen Marcozzi Pierce, MA, CNMT )
Study ID Numbers:	DHX4000
Study First Received:	January 21, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00606424 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Siemens Molecular Imaging:

head and neck cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009