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NCT02000778 · ClinicalTrials.gov registry record · Phase 1
EC17 for Intraoperative Imaging in Occult Ovarian Cancer
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02000778: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT02000778 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02000778, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The overall prevalence of Ovarian Cancer in the United States according to the US SEER Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age and decreases with numbers of pregnancies. The prognosis for many carcinomas is dependent on the extent of surgical resection. At present, the ability to perform a complete resection with negative margins is limited by the investigator's ability to palpate and visualize the tumor and its borders. In many cases, a more radical resection than necessary is performed in order to provide assurance that negative margins are achieved. This approach may also increase complication rates, as well as short- and long-term morbidity. It is desirable to improve visualization of primary tumors and occult metastases in real time, during surgery. The use of fluorescent probes that recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under investigation. Ovarian cancer is a prototypic disease for this type of clinical imaging system called intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen and typically involve extensions or implants onto pelvic or abdominal organs or membranes. Tumor debulking surgery is common early in the disease process as many of the tumors can be identified by appearance or feel in the skilled surgeon's hands. The major problems are that tumors can be diffuse and numerous, of various sizes, and often not readily visible in the surgical field. Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist at the FR-alpha with potential
Interventions
- DRUG EC17
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-11-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02000778
The ClinicalTrials.gov registry entry for NCT02000778 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EC17 is the first listed.
NCT02000778 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02000778 about?
NCT02000778 is a clinical study titled "EC17 for Intraoperative Imaging in Occult Ovarian Cancer". The overall prevalence of Ovarian Cancer in the United States according to the US SEER Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV it is only 20-25%. The majority of t...
What is the current status of trial NCT02000778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-11. Estimated completion is 2014-11-12.
What interventions are being tested in trial NCT02000778?
The interventions under investigation include: EC17 (DRUG).
Who is sponsoring clinical trial NCT02000778?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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