Intraoperative Imagery of Renal Nodules With Folate-fluorescein Conjugate(EC17)

June 29, 2018 updated by: Sunil Singhall, University of Pennsylvania

A Pilot and Feasibility Study Of The Imaging Potential Of EC17 In Subjects Undergoing Surgery Presenting With Renal Nodules

According to the National Cancer Institute, an estimated 64,770 men and women will be diagnosed with kidney cancer in 2012. Of this number, an estimated 13,570 will die of this disease. Surgery remains one of the best options for patients presenting with operable Stage II or III cancers, however the five year survival rate for these candidates remains at a dismal 63.7% for Stage II and 11% for Stage III. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through imaging during surgery it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival.

Renal cell malignancies are the ideal disease to investigate intra-operative imaging. 70% of kidney malignancies express folate receptor alpha (FRA). It is important to note that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. Thus, the false positive detection rate is expected to be extremely low. A group well known to us in the Netherlands has completed a pilot study utilizing a folate-FITC conjugate in 12 patients with ovarian cancer. Another group of investigators in Mayo have subsequently performed this study on 20 more patients without any serious adverse events (personal communication). They report excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). All side effects reversed when the injection was halted. Patients with a history of allergic reactions to insect bites should not participate (fluorescein is derived from the firefly insect, folate is an essential vitamin).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patients 18 years of age or older
  2. Patients presenting with a renal cell nodule or mass that are scheduled for open or laparoscopic resection based on clinical criteria
  3. Good operative candidate
  4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

  1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) test within 72 hours of surgery
  2. Patients with a history of anaphylactic reactions to Folate-FITC or insects

  3. At-risk patient populations

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

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

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 the EC17
Within two to four hours of injection of the 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC17 Renal Cell
  • 816726 (Other Identifier: 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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