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NCT01751529 · ClinicalTrials.gov registry record · Early Phase 1
Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer
A Early Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 48
- Enrollment target
NCT01751529: Completed Early Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT01751529 is a Early Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 48 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01751529, a Early Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).
Primary Outcome
Primary analyses will include 1) estimating the sensitivity of contrast enhanced ultrasound in Cohort 1 using the pathological outcome or biopsy result from ablative therapy as gold standard and 2) estimating sensitivity in Cohort 2 using pathology and follow-up results as gold standard (when tissue biopsy is not indicated nor surgery planned the truth standard diagnosis will be based on 12 month follow-up data of disease status). Exact 95% confidence intervals for sensitivity estimate will be r
Interventions
- DRUG Perflutren lipid
- PROCEDURE Contrast-enhanced Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-11 |
| Phase | Early Phase 1 |
What the finished NCT01751529 record still lists
NCT01751529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Perflutren lipid is the first listed.
NCT01751529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01751529 about?
NCT01751529 is a clinical study titled "Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer". This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound show...
What is the current status of trial NCT01751529?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 48 participants. The study started on 2013-05. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01751529?
The interventions under investigation include: Perflutren lipid (DRUG), Contrast-enhanced Ultrasound (PROCEDURE).
Who is sponsoring clinical trial NCT01751529?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01751529's enrollment target sits among peer trials
48 541st of 2000 higher than 1,438 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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