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:
Information provided by (Responsible Party):
Sean C. Dowdy, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01511055
First received: January 12, 2012
Last updated: August 6, 2014
Last verified: August 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 Names:
  • Folate-FITC
  • EC-17

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 12, 2012
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Ovarian Cancer

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

ClinicalTrials.gov processed this record on October 21, 2014