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

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ClinicalTrials.gov Identifier: NCT01778933
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : March 20, 2018
Information provided by (Responsible Party):
Sunil Singhall, University of Pennsylvania

Brief Summary:

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 or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: EC17 Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2013
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1 - Day 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778933

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

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 ( Other Identifier: UPenn IRB Protocol # )
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Sunil Singhall, University of Pennsylvania:
Renal cell carcinoma
Renal nodules

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