Intraoperative Imagery of Renal Nodules With Folate-fluorescein Conjugate(EC17)
Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Cell Carcinoma
Intervention: EC17 (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s): Sunil Singhal, M.D., Principal Investigator, Affiliation: University of Pennsylvania
Overall contact: Sunil Singhal, M.D., Email: sunil.singhal@uphs.upenn.edu
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).
Clinical Details
Official title: A Pilot and Feasibility Study Of The Imaging Potential Of EC17 In Subjects Undergoing Surgery Presenting With Renal Nodules
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration.
Secondary outcome: The number of participants that will have an adverse reaction to the EC17
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sunil Singhal, M.D., Email: sunil.singhal@uphs.upenn.edu
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Additional Information
Starting date: May 2013
Last updated: January 14, 2015
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