Phase II, Prospective, Non-Randomized Trial Investigating the Intra-Operative Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity and specificity of intra-operative imaging using Folate-FITC for identification of ovarian cancer metastatic to the peritoneum and lymph nodes

Outcome Description:

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 and specificity of this technique using microscopic analysis as the gold standard.

Outcome Time Frame:

1 week

Safety Issue:

No

Principal Investigator

Sean C Dowdy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

11-002980

NCT ID:

NCT01511055

Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

• Ovarian Cancer
• Ovarian Cancer
• Carcinoma
• Ovarian Neoplasms