Neoplasms Clinical Trial
Official title:
Intraoperative Imaging of Pulmonary Adenocarcinoma
The goal of this study is to perform imaging of patient's tumors while the chest is open and
the tumor is being removed.
According to the World Health Organization, lung cancer is the most common cause of
cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide
annually as of 2004. Surgery remains the best option for patients presenting with operable
Stage I or II cancers, however the five year survival rate for these candidates remains at a
dismal 53% for Stage I and 32% for Stage II. 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 us to improve the rates of
recurrence free patients and thus overall survival.
Thoracic malignancies are the ideal disease to investigate intra-operative imaging. Over 85%
of lung and pleural 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-fluorescein isothiocyanate (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).
Status | Completed |
Enrollment | 48 |
Est. completion date | May 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients over 18 years of age - Patients presenting with a lung or pleural nodule or mass presumed to be resectable on pre-operative assessment - Good operative candidate - Subject capable of giving informed consent and participating in the process of consent Exclusion Criteria: - Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery - Patients with a history of anaphylactic reactions to Folate-FITC or insects - At-risk patient populations: - Homeless patients - Patients with drug or alcohol dependence - Children and neonates - Patients unable to participate in the consent process |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | VA Office of Research and Development |
United States,
Okusanya OT, DeJesus EM, Jiang JX, Judy RP, Venegas OG, Deshpande CG, Heitjan DF, Nie S, Low PS, Singhal S. Intraoperative molecular imaging can identify lung adenocarcinomas during pulmonary resection. J Thorac Cardiovasc Surg. 2015 Jul;150(1):28-35.e1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of FRA tumors identified by EC17 during surgery. | Measure the number of patients who have a positive margin during lung cancer surgery 2 - 4 hours after receiving administration of EC17. | Within two to four hours of injection of the EC17 | No |
Secondary | The number of participants that will have an adverse reaction to the EC17 | Day 1 - Day 30 | Yes |
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