a Diagnosis of Any Resectable Lung or Pleural Nodule Clinical Trial
Official title:
A Pilot & Feasibility Study of Intraoperative Imaging With OTL38 In Patients With Lung and Pleural Nodules
| NCT number | NCT02769156 |
| Other study ID # | UPCC 04515 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | June 2015 |
| Est. completion date | December 2024 |
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Adverse Events | 3 years |