Intraoperative Imaging of Pulmonary Nodules by OTL38

NCT02602119 | Completed Phase 1 DMC

• 1 other identifier: 822153
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Ability of the imaging system to detect the expression of the OTL38 in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.

  Detected with imaging probe.

  5 years

• Microscopic examination and immunohistochemistry of tumor

  Performed by a pathologist. This will allow investigators to compare pathology results with video images taken by imaging probe to calculate false positive (i.e., identification of non FRA-positive tumors) rates of OTL38.

  5 years

Secondary Outcomes (1)

• Incidence rates of all AEs, treatment-emergent adverse events (TEAEs) and adverse device events (ADEs) from time of OTL38 administration through participants' first, post-operative appointment with surgeon.

  5 years

Study Arms (1)

OTL38

EXPERIMENTAL

Dosage calculated by weight of individual

Drug: OTL38

Interventions

OTL38 DRUG

Infusion of OTL38 prior to surgery

OTL38

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Pafolacianine

Study Officials

• Sunil Singhal, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 11, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

US (1)