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

This study is currently recruiting participants.
Verified November 2013 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: November 6, 2013
Last verified: November 2013
  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. 90% of kidney malignancies express folate receptor alpha (FRA), and a fluorescent probe targeting FRA is readily available. 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 the investigators in the Netherlands has completed a pilot study utilizing a folate- fluorescein isothiocyanate (FITC) conjugate in 12 patients with ovarian cancer. They have subsequently performed this study on 20 more patients without any 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. The only known allergy is those patients which have an insect reaction (fluorescein is derived from the firefly insect, folate is an essential vitamin). This drug has also been used at a higher dose for therapeutic purposes in patients with metastatic renal cell carcinoma in the United States. However, this drug will be used at a lower dose for a diagnostic purpose only.


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 the imaging system to detect the expression of EC17 in the nodule/mass (i.e. tumor) and discern the uptake of the dye by the tumor [ Time Frame: Within two 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
This group will receive a single dose of EC17, infused over 10 minutes, prior to surgery. Then, during surgery, they will be image with the camera and imaging probe 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 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
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

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: November 6, 2013
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 April 15, 2014