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

This study has been terminated.
(Accrual temporarily suspended, followed by study closure due to technical problems with investigational camera.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511055
First Posted: January 18, 2012
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sean C. Dowdy, Mayo Clinic
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer Drug: EC-17 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Sean C. Dowdy, Mayo Clinic:

Primary Outcome Measures:
  • Sensitivity and specificity of intra-operative imaging using Folate-FITC for identification of ovarian cancer metastatic to the peritoneum and lymph nodes [ Time Frame: 1 week ]
    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.


Secondary Outcome Measures:
  • Confirmation of low to absent rates of significant adverse events following a one-time dose of folate-FITC (EC-17). [ Time Frame: Duration of hospitalization with a maximum of 7 days ]
    Subjects 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.


Enrollment: 21
Study Start Date: January 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Folate-FITC Drug: EC-17
One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Other Name: Folate-FITC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511055


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Sean C Dowdy, MD Mayo Clinic
  More Information

Responsible Party: Sean C. Dowdy, Associate Professor - Obstetrics and Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01511055     History of Changes
Other Study ID Numbers: 11-002980
First Submitted: January 12, 2012
First Posted: January 18, 2012
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by Sean C. Dowdy, Mayo Clinic:
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs