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NCT00565721 · ClinicalTrials.gov registry record · Phase 2
A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and Angiogenesis
A Phase 2 study, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT00565721 is a Phase 2 study that has completed, run by GE Healthcare. The registered enrollment target is 33 participants.
The verdict
NCT00565721, a Phase 2 study, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This proof-of-concept study is designed to assess the ability of \[18F\]AH-111585 PET imaging to detect tumors and angiogenesis. Up to 30 evaluable subjects are planned to be included at up to 2 study centers in the US. Subjects are considered evaluable if they undergo administration of AH-111585 (18F) Injection, dynamic and static PET imaging, and tumor tissue acquisition. The targeted population is adult subjects at initial diagnosis or recurrence with tumors ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumor as a result of routine clinical treatment. The tumors must belong to one of the following 5 types: * High-grade glioma, including glioblastoma multiforme, anaplastic astrocytoma, and anaplastic oligodendroglioma * Lung cancer, including small cell lung cancer and non-small cell lung cancer * Head and neck (H\&N) tumors, including laryngeal squamous cell carcinoma, well-differentiated thyroid and oral cavity carcinoma * Sarcoma * Melanoma Safety will be assessed from the rates of adverse events, changes in vital signs, changes in electrocardiogram (ECG) parameters, changes in physical examination findings, and changes in clinical laboratory findings. Efficacy will be assessed as the correlations between parameters derived from the PET images and the reference standards. The reference standards will be immunohistology for αvβ3 integrins and other biomarkers specific for oncology and angiogenesis and from the standard of care imaging. Measures obtained from optional DCE-CT imaging may also be used to compare the uptake and retention of \[18F\]AH-111585 in tumors obtained from the dynamic PET to assess functional status of the vascular system of the tumor.
Interventions
- DRUG Fluciclatide Injection - (AH111585 (F18))
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00565721
The ClinicalTrials.gov registry entry for NCT00565721 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fluciclatide Injection - (AH111585 (F18)) is the first listed.
NCT00565721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00565721 about?
NCT00565721 is a clinical study titled "A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and Angiogenesis". This proof-of-concept study is designed to assess the ability of \[18F\]AH-111585 PET imaging to detect tumors and angiogenesis. Up to 30 evaluable subjects are planned to be included at up to 2 study centers in the US. Subjects are considered evaluable if they undergo administration of AH-111585 (1...
What is the current status of trial NCT00565721?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2007-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00565721?
The interventions under investigation include: Fluciclatide Injection - (AH111585 (F18)) (DRUG).
Who is sponsoring clinical trial NCT00565721?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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