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NCT00884520 · ClinicalTrials.gov registry record · Early Phase 1
An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037
A Early Phase 1 study, sponsored by Siemens Molecular Imaging.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT00884520: Completed Early Phase 1 study, sponsored by Siemens Molecular Imaging.
NCT00884520 is a Early Phase 1 study that has completed, run by Siemens Molecular Imaging. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00884520, a Early Phase 1 study, has completed, sponsored by Siemens Molecular Imaging.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Phase: Exploratory Study Objectives: To collect drug bio-distribution data, begin collection of baseline and tumor/background imaging data, acquire experience to improve study design and the conduct of future studies Design: Exploratory, open label, nonrandomized, multi-center study Duration: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose Procedures: Informed consent, collection of demographic information and medical history, physical examinations, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, blood sample for CA-IX assay, pre-dose and post-dose blood samples for metabolite analysis, dosing with \[F-18\]VM4-037, PET imaging scan, dosimetry estimation (normals), urine collections (normals), tumor immunohistochemistry with CA-IX biomarker, follow up to imaging to collect adverse events Subjects: Approximately sixteen (16) adult subjects including four (4) healthy volunteers and twelve (12) cancer subjects who have confirmed or highly suspected diagnosis of head \& neck, lung, large solitary hepatic and renal cell cancer, as defined by protocol criteria
Interventions
- DRUG [F-18] VM4-037
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-03 |
| Phase | Early Phase 1 |
What the finished NCT00884520 record still lists
NCT00884520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which [F-18] VM4-037 is the first listed.
NCT00884520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00884520 about?
NCT00884520 is a clinical study titled "An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037". Phase: Exploratory Study Objectives: To collect drug bio-distribution data, begin collection of baseline and tumor/background imaging data, acquire experience to improve study design and the conduct of future studies Design: Exploratory, open label, nonrandomized, multi-center study Duration: Thr...
What is the current status of trial NCT00884520?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2009-04. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00884520?
The interventions under investigation include: [F-18] VM4-037 (DRUG).
Who is sponsoring clinical trial NCT00884520?
This trial is sponsored by Siemens Molecular Imaging, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00884520's enrollment target sits among peer trials
16 1370th of 2000 higher than 598 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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