Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand

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.

Inclusion Criteria:

Women who are:

• Diagnosed with or at high clinical suspicion of primary ovarian cancer by either radiologic imaging or physical examination or biopsy or serum tumor markers
• Scheduled to undergo surgical cytoreduction via laparotomy
• At least 18 years of age
• Capable and willing to provide informed consent

Exclusion Criteria:

Women with:

• Known sarcomatous histologies
• Recurrent ovarian cancer
• Planned surgical approach via laparoscopy or robotic surgery
• A history of anaphylactic reactions to Folate-FITC or insects
• Inability or unwillingness to provide informed consent