Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Early Phase 1 study that has completed, run by Siemens Molecular Imaging. The registered enrollment target is 16 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00884520
The ClinicalTrials.gov registry entry for NCT00884520 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 16 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 [F-18] VM4-037 is the first listed.
NCT00884520 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.