Suzanne Rose, MS, PhD, CCRC, FACRP, Director, Office of Research at Stamford Health

The Stamford Health Office of Research is excited to announce the launch of a new clinical trial for lung cancer in collaboration with the Carl & Dorothy Bennett Cancer Center with Michael Ebright, MD, Director of Thoracic Surgery at Stamford Hospital as Principal Investigator.

Dr. Ebright is excited to offer this trial to our patients. “We will be investigating the utility of ‘fluorescence-guided surgery’ to find previously undetected cancer sites during surgery to achieve a more complete [removal of the cancerous area]. This has the potential to change the standard of care for lung cancer surgery, and represents the leading edge of technology in intraoperative imaging. We are proud to offer this trial to our patients.”

The clinical trial, named ELUCIDATE, is formally termed, “A Phase 3, Randomized, Single dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules.” Its name ELUCIDATE stands for Enabling Lung Cancer Identification Using Folate Receptor Targeting.

Stamford Hospital is one of only 13 sites nationwide and the only site in the New York metropolitan area to offer this groundbreaking trial to patients with lung cancer or suspected lung cancer.

We sat down with Dr. Suzanne Rose, Director of the Office of Research at Stamford Health, to get the full story on this innovative opportunity in the world of lung cancer. Dr. Rose was recently named a Fellow of the Association of Clinical Research Professionals, of which there are less than 45 worldwide. Below, she shares details of the ELUCIDATE trial.

What is a clinical trial?

A clinical trial is a research study performed in patients. It is aimed at evaluating an intervention with a drug or medical device. A clinical trial is the main way that researchers find out if a new treatments are safe and effective.

What is folate receptor targeting, as mentioned above?

Folate receptor targeting is a method that binds the vitamin, folate, with folic acid in order to help doctors better target cancer cells. This method has been around for quite some time and is effective for certain, not all, cancers.

How does the ELUCIDATE clinical trial use folate receptor targeting to work?

The most noteworthy part of the trial is the fluorescent “light-up” technology that helps researchers and physicians visualize the cancer cells through a camera.

• In order for this to happen, ELUCIDATE uses a drug, called OTL38, which has a special version of folate that allows for it to “glow” under fluorescent light.
• Patients in the study receive an infusion with OTL38 two to three hours before their surgery. The drug, OTL38, attaches to cancer cells and lights up when visualized through a special camera system.
• Certain cancer cells have folate receptors on their surface, which “stick” to the vitamin folate. If this version of folate also glows under fluorescent light, doctors can see the cancer cells with this camera when performing surgery. Some cancerous areas may not have been visible using standard techniques.

How does ELUCIDATE benefit both the patient and their cancer surgeon?

Typically, to determine the size and location of a tumor or a potential tumor, surgeons will use several types of imaging before surgery, such as CT scans and PET scans. However, these types of imaging are not usually available during surgery.

Using OTL38 in the operating room may help the surgeon see the cancer better during the operation, which may help them remove previously undetected cancers.

For patients, the surgeon’s ability to visualize the cancer cells inside the operating room in real time may reduce the need for additional operations and increase their overall chances of survival.

Who is eligible for the ELUCIDATE clinical trial?

This clinical trial includes patients who have lung cancer or who are suspected of having lung cancer and will be undergoing surgery as part of treatment, such as removing part of the lung or the entire lung itself.

How many patients is the trial recruiting and what is Stamford Health's involvement?

The ELUCIDATE trial will recruit up to 130 patients. To find more information on this trial, you can visit the clinicaltrials.gov website.

Dr. Michael Ebright, mentioned above, has previously published a paper on this topic in The Journal of Thoracic and Cardiovascular Surgery titled, "Seeing Cancer in a New Light."

According to Edward Hatton, RN, Lead Clinical Research Nurse on this trial from the Office of Research, “Stamford Hospital trial participants will have access to a novel diagnostic assessment that has the potential to become a new standard of care.”

How can I find out more about clinical trials at Stamford Health?

The Office of Research, directed by Dr. Suzanne Rose, coordinates research projects, including both in-hospital and outpatient settings for both the Stamford Health Medical Group and physicians in private practice. For more information on the other types of clinical trials we offer at Stamford Health, please visit our website or email us at [email protected].