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NCT01212965 · ClinicalTrials.gov registry record · Phase 1
Selenium in the Treatment of Complicated Lymphatic Malformations
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01212965: Clinical Trial Phase 1 study, sponsored by Medical College of Wisconsin.
NCT01212965 is a Phase 1 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212965, a Phase 1 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The investigators propose a pilot trial to obtain preliminary information regarding the safety and response rate of patients with symptomatic lymphatic malformations treated with oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2 clinical trials. Hypotheses: * Selenium will be safe and efficacious in the treatment of adolescents and young adults with symptomatic lymphatic malformations * Disease response will correlate with serum levels of selenium and blood levels of antioxidants essential to selenium metabolism.
Primary Outcome
Disease will be assessed by volumetric MRI and patient quality of life assessments at 6 months of therapy and compared to pretreatment values.
Interventions
- DRUG Selenium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
Why NCT01212965 stopped before completion
NCT01212965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Selenium is the first listed.
NCT01212965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01212965 about?
NCT01212965 is a clinical study titled "Selenium in the Treatment of Complicated Lymphatic Malformations". The investigators propose a pilot trial to obtain preliminary information regarding the safety and response rate of patients with symptomatic lymphatic malformations treated with oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2 clinical trials. Hypotheses:...
What is the current status of trial NCT01212965?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01212965?
The interventions under investigation include: Selenium (DRUG).
Who is sponsoring clinical trial NCT01212965?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01212965's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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