Cytalux (OTL-38)

Overview: 

Folate-targeted near infrared dye for fluorescence-guided surgery of various cancers.  Cytalux (OTL-38) was approved by the FDA for the detection of ovarian cancer in 2021 and lung cancer in 2022 during fluorescence-guided surgeries.  Cytalux is being studied in various other clinical trials to test its ability to detect other types of cancer during fluorescence-guided surgeries.  

Status: 

Purdue Faculty: 

Dr. Philip Low

Clinical Trial Information: 

Phase 2 Trial - OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

Phase 2 Trial - Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

Phase 1 Trial - Intraoperative Imaging of Pulmonary Nodules by OTL38

Phase 1 Trial - Intraoperative Imaging of Pituitary Adenomas by OTL

Phase 1 Trial - A Pilot & Feasibility Study of Intraoperative Imaging With OTL38 In Patients With Lung and Pleural Nodules

Phase 1 Trial - A Phase 1, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Pituitary Adenoma

Phase 1 Trial - Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

Phase 1 Trial - Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry

Development Partner: 

Research Articles: 

Novel Use of Folate-Targeted Intraoperative Fluorescence, OTL38, in Robot-Assisted Laparoscopic Partial Nephrectomy: Report of the First Three Cases

A Novel Tumor-Specific Agent for Intraoperative Near-Infrared Fluorescence Imaging: A Translational Study in Healthy Volunteers and Patients with Ovarian Cancer

Intraoperative tumor-specific fluorescence imaging in ovarian cancer by folate receptor-α targeting: first in-human results

Intraoperative molecular imaging can identify lung adenocarcinomas during pulmonary resection

Development of Tumor-Targeted Near Infrared Probes for Fluorescence Guided Surgery