Clinical trial · Interventional
Intraoperative Imaging of Pulmonary Nodules by OTL38
NCT02602119CI-TRIAL-00059346completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OTL38 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OTL38
- description
- Dosage calculated by weight of individual
- interventionNames
- Drug: OTL38
Primary outcomes (2)
- measure
- 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.
- timeFrame
- 5 years
- description
- Detected with imaging probe.
- measure
- Microscopic examination and immunohistochemistry of tumor
- timeFrame
- 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.