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

Mayo Clinic

Status and phase

Terminated

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: EC-17

Study type

Interventional

Funder types

Other

Identifiers

NCT01511055

11-002980

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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: