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

NCT01511055 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 11-002980
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Grade 4 or Higher Adverse Events Following a One-time Dose of Folate-FITC (EC-17).

  Duration of hospitalization with a maximum of 7 days

Study Arms (1)

Folate-FITC

EXPERIMENTAL

Drug: EC-17

Interventions

EC-17 DRUG

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

Also known as: Folate-FITC

Folate-FITC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Limitations and Caveats

The investigational camera was instrumental for collecting data for this study. Due to technical problems with the camera from the onset of the study, the study was terminated and no data was able to be collected or analyzed.

Results Point of Contact

• Title: Sean C. Dowdy, M.D.
• Organization: Mayo Clinic

Dowdy.Sean@mayo.edu

507-266-0225

Study Officials

• Sean C Dowdy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 12, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-10

Locations

US (1)