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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Sunil Singhall, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01778933
First received: January 18, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Renal Cell Carcinoma
Drug: EC17
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot and Feasibility Study Of The Imaging Potential Of EC17 In Subjects Undergoing Surgery Presenting With Renal Nodules

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1 - Day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01778933

Contacts
Contact: Sunil Singhal, M.D. sunil.singhal@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Sunil Singhal, M.D. University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Sunil Singhall, Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01778933     History of Changes
Other Study ID Numbers: EC17 Renal Cell, 816726
Study First Received: January 18, 2013
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Renal cell carcinoma
Renal nodules

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014