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NCT00606424 · ClinicalTrials.gov registry record · Early Phase 1
An Exploratory, Open Label, Single Center Study of [F-18]HX4
A Early Phase 1 study, sponsored by Siemens Molecular Imaging.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT00606424 is a Early Phase 1 study that has completed, run by Siemens Molecular Imaging. The registered enrollment target is 10 participants.
The verdict
NCT00606424, a Early Phase 1 study, has completed, sponsored by Siemens Molecular Imaging.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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 wi
Interventions
- DRUG 20 mCi dose for a 50 kg individual of [F-18]HX4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00606424
The ClinicalTrials.gov registry entry for NCT00606424 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Siemens Molecular Imaging, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 20 mCi dose for a 50 kg individual of [F-18]HX4 is the first listed.
NCT00606424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00606424 about?
NCT00606424 is a clinical study titled "An Exploratory, Open Label, Single Center Study of [F-18]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 hypo...
What is the current status of trial NCT00606424?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2008-01. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00606424?
The interventions under investigation include: 20 mCi dose for a 50 kg individual of [F-18]HX4 (DRUG).
Who is sponsoring clinical trial NCT00606424?
This trial is sponsored by Siemens Molecular Imaging, which has 9 total clinical trials registered on ClinicalTrials.gov.
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