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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01511055
• Other study ID #: 11-002980
• Status: Terminated
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• EC-17
One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of Intra-operative Imaging Using Folate-FITC for Identification of Ovarian Cancer Metastatic to the Peritoneum and Lymph Nodes	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.	1 week
Secondary	Number of Participants With Grade 4 or Higher Adverse Events Following a One-time Dose of Folate-FITC (EC-17).	Study participants will be followed and all adverse events will be captured for the duration of hospitalization following administration of investigational product, up to a maximum of 7 days following IP administration and surgical procedure. Adverse Events will be classified as: grade 1=Mild, grade 2=Moderate, grade 3=Severe, grade 4=Life-threatening/disabling, grade 5 =Death. Significant is defined as adverse events grade 4 or higher.	Duration of hospitalization with a maximum of 7 days

External Links

•   Mayo Clinic Clinical Trials