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March 27, 2023 — On Target Laboratories, Inc., a privately held biotechnology company developing intraoperative molecular imaging (IMI) agents to target and illuminate cancer during surgery, announced publication of results from the ELUCIDATE Phase 3 Trial of CYTALUX (pafolacianine) injection for use of IMI for cancer in the lung. The results were published in the peer-reviewed Journal of Thoracic and Cardiovascular Surgery. In December 2022, the U.S. Food and Drug Administration expanded the indication of CYTALUX after previously granting approval for ovarian cancer in 2021, making it the first and only targeted molecular imaging agent that intraoperatively illuminates lung and ovarian cancers in real-time during surgery.
In the ELUCIDATE trial (n=112), patients with suspected or biopsy-confirmed cancer in the lung scheduled for lung resection were administered CYTALUX intravenously within 24 hours before surgery. The research article reports that, in patients randomized to receive IMI with CYTALUX, a clinically significant event (CSE) occurred in 53% of patients (N=53 out of 100, p < 0.0001).* CSEs included locating the primary lesion that the surgeon could not otherwise locate with conventional techniques in 19% of patients, discovery of one or more additional cancerous lesions which was previously unknown in 8% of patients, and identification of a close resection margin (10mm) in 38% of patients. Among additional cancerous lesions discovered with CYTALUX, 73% were outside the planned resection field. Overall, surgeons reported changing the scope of their surgical plan in 29% patients (22 increase, 7 decrease). No drug-related serious adverse events occurred.
"Identification of lesions during surgery can be challenging, especially if the lesions are small or deep below the surface of the lung," said Inderpal Sarkaria, MD, Thoracic Surgeon at the University of Pittsburgh Medical Center and lead author on the publication. "Our research confirmed that CYTALUX helps surgeons more easily visualize lesions and detect additional cancer at one of the most critical moments – during their operation."
"We're thrilled that this trial contributed to CYTALUX being available as a first-in-class agent to aid thoracic surgeons in visualizing otherwise undetectable cancerous lesions in the lung," said Chris Barys, President, Chief Executive Officer and Board Member of On Target Laboratories. "We believe that the adjunctive use of CYTALUX during lung cancer surgery will add significant value to surgeons, helping them make decisions in real-time that potentially lead to removing more cancer from their patient and improving outcomes."
* N=53 out of 100 patients with cancer in the lung. CYTALUX USPI describes a clinically significant event rate of 24% (N=24 out of 100) based on localization of the primary lesion (N=19 out of 100, 19%) and identification of a synchronous cancerous lesions (N=8 out of 100, 8%).
About the ELUCIDATE Trial
The ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) trial was a Phase 3, multi-center, single dose, open label trial and included 12 sites across the United States. The clinical trial (NCT04241315) investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.
About Intraoperative Molecular Imaging
To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.
For more information: www.ontargetlabs.com and www.cytalux.com.
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