A Pilot & Feasibility Study of Intraoperative Imaging With OTL38 In Patients With Lung and Pleural Nodules
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/2/2018 |
| Start Date: | June 2015 |
| Contact: | Sunil Singhal, MD |
| Email: | PennCancerTrials@emergingmed.com |
| Phone: | 855-216-0098 |
This pilot and feasibility study is focusing on patients presenting with suspected
malignancies of the lung and pleura who are considered to be good surgical candidates. The
primary end-point of the study is to determine the sensitivity of OTL uptake and expression
in identifying those lung and pleural nodules when excited by an imaging probe. There will be
a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, two to
three hours, prior to surgery.
malignancies of the lung and pleura who are considered to be good surgical candidates. The
primary end-point of the study is to determine the sensitivity of OTL uptake and expression
in identifying those lung and pleural nodules when excited by an imaging probe. There will be
a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, two to
three hours, prior to surgery.
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 hCG within 72 hours of surgery
- Patients with a history of anaphylactic reactions to OTL38
- Patients with a known allergy to Benadryl
- At-risk patient populations
- Homeless patients
- Patients with drug or alcohol dependence
- Children and neonates
- Patients unable to participate in the consent process
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Sunil Singhal, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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