Intraoperative Imaging of Pulmonary Nodules by OTL38

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary end-point of the study is to determine the sensitivity of OTL in identifying lung nodules when excited by an imaging probe. Investigators intend to enroll 300 lung cancer patients in this study. The study is focusing on patients presenting with suspected malignancies of the lung and pleura who are considered to be good surgical candidates.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania

Criteria

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.