Intraoperative Imaging of Pulmonary Nodules by OTL38
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|ClinicalTrials.gov Identifier: NCT02602119|
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: OTL38||Phase 1|
According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.5 million deaths worldwide annually as of 2012. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 73% for Stage I and 53% for Stage II. The high rates of local recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through imaging during surgery it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival.
Thoracic malignancies are the ideal disease to investigate intra-operative imaging. Over 85% of lung and pleural malignancies express folate receptor alpha (FRA), therefore making folate receptors (FR) the ideal targets for imaging agents. While folate will initially distribute to all cells, redistribution, metabolism, and excretion will eliminate most of this agent from healthy tissues within hours. Tumor cells that over express FRα will retain folate and any fluorescent labeled folate conjugate and internalize this. It is important to note that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. However, the fluorescence signal in the kidneys is expected to be significantly lower than the tumor tissues. Thus, the false positive detection rate is expected to be extremely low.
The investigators have conducted a Phase I clinical trial with folate-FITC in 50 patients with lung cancer. In the study at UPenn, the investigators had no adverse events. The investigators had excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). All side effects reversed when the injection was halted. This study confirmed that FRA is a reasonable target for lung cancer.
On Target Laboratories, LLC has developed OTL38. Compared with some of the existing fluorescent imaging agents, OTL38 is associated with less auto-fluorescence due to its near-IR excitation wavelength and can be seen through blood and tissues up to 1.5 cm thickness. Thus, in this study, the investigator's goal has changed from the folate-FITC formulation to the OTL38 formulation. The fluorophore component of the drug is new, whereas the target and design of the study remain unchanged.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraoperative Imaging of Pulmonary Nodules by OTL38|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Dosage calculated by weight of individual
Infusion of OTL38 prior to surgery
- 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. [ Time Frame: 5 years ]Detected with imaging probe.
- Microscopic examination and immunohistochemistry of tumor [ Time Frame: 5 years ]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.
- 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. [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602119
|Contact: Sunil Singhal, MD||215-662-4767|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Sunil Singhal, MD 215-662-4767|
|Principal Investigator: Sunil Singhal, M.D.|
|Principal Investigator:||Sunil Singhal, MD||University of Pennsylvania|