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Phase II, Prospective, Non-Randomized Trial Investigating the Intra-Operative 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 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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Mayo Clinic
Rochester, Minnesota, United States
Start Date
January 1, 2012
Primary Completion Date
June 1, 2014
Completion Date
June 1, 2014
Last Updated
November 12, 2020
27
ACTUAL participants
EC-17
DRUG
Lead Sponsor
Mayo Clinic
NCT04550494
NCT05039801
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