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Head and Neck CancerEarly Phase 1HX4NCT00606424

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

A Early Phase 1 study testing 20 mCi dose for a 50 kg individual of [F-18]HX4 in people with Head and Neck Cancer, run by Siemens Molecular Imaging at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Head and Neck Cancer
What is being tested?
20 mCi dose for a 50 kg individual of [F-18]HX4
Type of treatment
Injection or infusion
How many people
10 participants
Where
1 siteUnited States
Study dates
Jan 2008to Jan 2009
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Michael Yu, MD

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

[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.

Read more

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.

Being tested
20 mCi dose for a 50 kg individual of [F-18]HX4
Keywords
head and neck cancer
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20 mCi dose for a 50 kg individual of [F-18]HX4Drug

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00606424
Sponsor's protocol ID
DHX4000
Acronym
HX4
Status last verified
Jan 2009
First submitted
21 Jan 2008
Last updated
2 Feb 2009
Results posted
No
Data monitoring committee
No

Publications

  • Doss M, Zhang JJ, Belanger MJ, Stubbs JB, Hostetler ED, Alpaugh K, Kolb HC, Yu JQ. Biodistribution and radiation dosimetry of the hypoxia marker 18F-HX4 in monkeys and humans determined by using whole-body PET/CT. Nucl Med Commun. 2010 Dec;31(12):1016-24. doi: 10.1097/MNM.0b013e3283407950.

    PubMed 20948452

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 20 mCi dose for a 50 kg individual of [F-18]HX4 in people with Head and Neck Cancer, run by Siemens Molecular Imaging at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00606424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2009.

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