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

NCT ID: NCT01778933

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-09-30

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).

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EC17

Intervention Type: DRUG

Interventions

EC17

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Sunil Singhall

Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunil Singhal, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Guzzo TJ, Jiang J, Keating J, DeJesus E, Judy R, Nie S, Low P, Lal P, Singhal S. Intraoperative Molecular Diagnostic Imaging Can Identify Renal Cell Carcinoma. J Urol. 2016 Mar;195(3):748-55. doi: 10.1016/j.juro.2015.09.093. Epub 2015 Nov 2.

Reference Type: RESULT

PMID: 26541080 (View on PubMed)

Other Identifiers

816726

Identifier Type: OTHER

Identifier Source: secondary_id

EC17 Renal Cell

Identifier Type: -

Identifier Source: org_study_id