EC17 for Intraoperative Imaging for Parathyroidectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Sunil Singhall, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01996072
First received: November 21, 2013
Last updated: June 17, 2014
Last verified: November 2013
  Purpose

Primary hyperparathyroidism is a significant medical and public health problem in the world and affects approximately 100,000 new patients in the United States alone. If left untreated this can lead to renal stones, osteoporosis, fatigue, and depression. The best treatment for primary hyperparathyroidism is surgical parathyroidectomy. However surgical parathyroidectomy can be difficult due to the variant location of the parathyroid glands. Up to 5% of patients leave the operating room without surgical cure.

Primary hyperparathyroidism is an ideal disease to investigate intraoperative fluorescent imaging. This would allow surgeons to identify the parathyroid glands and resect the suspicious parathyroid glands. Folate receptor (FR) has been found to be over-expressed in parathyroid tissue and not thyroid issues. An ideal surgical treatment would combine FR-specific fluorescent tracers with intraoperative imaging. It is important to note that FR 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).

A fluorescent contrast agent (folate-FITC or EC17) will be used to determine if it will localize to the primary tumor nodule(s) or mass(es) of patients undergoing parathyroid surgery.


Condition Intervention Phase
Primary Hyperparathyroidism
Drug: EC17
Phase 1

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 & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Parathyroidectomy for Primary Hyperparathyroidism.

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 EC17 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 10
Study Start Date: November 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
Other Name: Folate- FITC

  Eligibility

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

Inclusion Criteria:

  1. Adult patients over 18 years of age
  2. Patients presenting with primary hyperparathyroidism presumed to be resectable on pre-operative assessment
  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 hCG within 72 hours of surgery
  2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
  3. Vulnerable patient populations

    1. Homeless patients
    2. Patients with drug or alcohol dependence
    3. Children and neonates
    4. 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: NCT01996072

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
Principal Investigator: Sunil Singhal, M.D.         
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 Proffesor of Medicine, Assistant Proffesor of Surgery, Director Thoracic Surgery Research Lab, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01996072     History of Changes
Other Study ID Numbers: 818060, 818060 [UPenn IRB Protocol]
Study First Received: November 21, 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:
Primary hyperparathyroidism
Parathyroid

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Endocrine System Diseases
Parathyroid Diseases

ClinicalTrials.gov processed this record on October 22, 2014