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NCT01511055 · ClinicalTrials.gov registry record · Phase 2
Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand
A Phase 2 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT01511055: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT01511055 is a Phase 2 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01511055, a Phase 2 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and costs while maintaining or improving surgical and oncologic outcomes, the investigators must develop technologies that improve visualization of the primary tumor and occult metastases, real time, during surgery. Recent research has demonstrated that the use of fluorescent probes that recognize cancer specific antigens can be used for this purpose when visualized using a prototype near-infrared multispectral imaging system. This investigation will determine if folate-FITC, a fluorescent probe that recognizes the folate receptor (present in \> 90% of ovarian cancers) can facilitate surgical resection and detect tumor nodules not visible to the naked eye.
Primary Outcome
A maximum of 5 nodules less than 1cm in size will be identified in each patient with the naked eye and then visualized with the camera. The nodules will be biopsied after determining if they are fluorescent positive or negative (F+ or F-), and examined microscopically to confirm if carcinoma is present. Up to 5 F+ lesions that were not identified with the naked eye will also be biopsied and examined microscopically to determine if carcinoma is present. These data will establish the sensitivity a
Interventions
- DRUG EC-17
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
Why NCT01511055 stopped before completion
NCT01511055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which EC-17 is the first listed.
NCT01511055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01511055 about?
NCT01511055 is a clinical study titled "Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand". Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margin...
What is the current status of trial NCT01511055?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2012-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01511055?
The interventions under investigation include: EC-17 (DRUG).
Who is sponsoring clinical trial NCT01511055?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01511055's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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