EC17 for Intraoperative Imaging in Occult Ovarian Cancer

June 1, 2018 updated by: University of Pennsylvania

A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Intraoperative Detection of Occult Ovarian Carcinoma

The overall prevalence of Ovarian Cancer in the United States according to the US SEER Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age and decreases with numbers of pregnancies.

The prognosis for many carcinomas is dependent on the extent of surgical resection. At present, the ability to perform a complete resection with negative margins is limited by the investigator's ability to palpate and visualize the tumor and its borders. In many cases, a more radical resection than necessary is performed in order to provide assurance that negative margins are achieved. This approach may also increase complication rates, as well as short- and long-term morbidity. It is desirable to improve visualization of primary tumors and occult metastases in real time, during surgery. The use of fluorescent probes that recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under investigation.

Ovarian cancer is a prototypic disease for this type of clinical imaging system called intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen and typically involve extensions or implants onto pelvic or abdominal organs or membranes. Tumor debulking surgery is common early in the disease process as many of the tumors can be identified by appearance or feel in the skilled surgeon's hands. The major problems are that tumors can be diffuse and numerous, of various sizes, and often not readily visible in the surgical field.

Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist at the FR-alpha with potential uses for imaging and targeted therapeutic strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens examined by immunohistochemistry, so prior treatment is unlikely to affect utility of FR-alpha agonists as imaging or therapeutic agents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Female subjects 18 years of age and older
  2. Female subjects of childbearing potential or less than 2 years postmenopausal agree to receive a urinary or serum beta HCG test prior to subject enrollment. Documentation must be acquired for women of menopausal or post-menopausal status prior to subject enrollment if they are below the age of sixty (60).

  3. Primary diagnosis, or at high clinical suspicion, of primary ovarian cancer:

    1. Patient is scheduled to undergo laparotomy OR
    2. Patient is scheduled to undergo laparoscopy then pre-authorized laparotomy if cancer is found.

Exclusion Criteria:

1. Known sarcomatous histologies

  1. Recurrent ovarian cancer
  2. Known FR-alpha negative cancer
  3. Planned surgical approach via laparoscopy or robotic (no intention to perform laparotomy)
  4. History of anaphylactic reactions to Folate-FITC (EC17) or insects
  5. Pregnancy
  6. Brain metastases
  7. Taking compounds that inhibit active transport of organic anions (probenecid)
  8. Hepatic impairment, as evidenced by greater than 3x the upper limit of normal (ULN) for ALT, AST, or total bilirubin (except for known cases of Gilbert's syndrome), or renal impairment, as evidenced by greater than 1.5x the ULN for BUN or creatinine
  9. Received study agent in another investigational drug or vaccine trial prior to surgery

  10. At-risk patient populations

    1. People who would easily be lost to follow up (ex: People who are homeless or alcohol dependent)
    2. Patients unable to participate in the consent process (children and neonates)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EC17 Injection Group
The group will receive a single dose of EC17, infused over 10 minutes, prior to surgery. Then, during surgery, the EC-17 will be imaged with a camera that the investigators have developed.
Drug: EC17
Other Names:
  • Folate-FITC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration.
Time Frame: Within two to four hours of injection of EC17
Within two to four hours of injection of EC17

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of participants that will have an adverse reaction to the EC17
Time Frame: Day 1-Day 30
Day 1-Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Sunil Singhal, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 12, 2014

Study Completion (Actual)

November 12, 2014

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 818533
  • 818533 [UPenn IRB Protocol #]

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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