EC17 for Intraoperative Imaging for Parathyroidectomy

NCT ID: NCT01996072

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-09-30

Brief Summary

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.

Conditions

Primary Hyperparathyroidism

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

Other Intervention Names

Folate- FITC

Eligibility 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

• 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 Proffesor of Medicine, Assistant Proffesor of Surgery, Director Thoracic Surgery Research Lab

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

Other Identifiers

818060 [UPenn IRB Protocol]

Identifier Type: OTHER

Identifier Source: secondary_id

818060

Identifier Type: -

Identifier Source: org_study_id