Pilot Study on Using CYTALUX for Detecting Cancer During Surgery
Sponsor: John Waters
ClinicalTrials ID:NCT07039526
This study is testing a drug called CYTALUX, which helps doctors see cancer cells during surgery by making them light up. It's for adults with certain types of cancer who are having surgery to remove tumors.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to test a drug called CYTALUX (pafolacianine) that helps doctors see cancer cells during surgery. CYTALUX attaches to cancer cells and lights up when viewed through a special camera, making it easier for surgeons to find and remove cancerous tissue. This study is for adults who are suspected to have certain types of cancer, such as gastrointestinal, pancreatic, or gynecological cancers, and are scheduled for surgery. Participants will receive the drug before their surgery, and during the operation, doctors will use a special camera to see if the cancer cells light up, helping them to remove the cancer more effectively. The study will last about 2 months.
Description
This study is exploring a new way to help surgeons see cancer cells more clearly during surgery. CYTALUX is a drug that attaches to cancer cells and makes them glow under a special camera. This can help doctors find and remove cancer more accurately. The drug is given through an IV before surgery, and it works by targeting a specific marker found on many cancer cells. Once inside the body, it quickly leaves normal tissues but stays in cancer cells, making them visible during surgery. This approach could improve the chances of removing all cancerous tissue and reduce the risk of cancer coming back. The study will also look at how safe the drug is and whether it causes any side effects. Participants will receive a single dose of CYTALUX before their surgery, and doctors will use a special camera to look for glowing cancer cells during the operation. The study aims to find out if this method can help detect more cancerous tissue than standard techniques alone.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older.
- Have a confirmed or suspected diagnosis of certain cancers, such as gastrointestinal, pancreatic, or gynecological cancers, and are scheduled for surgery.
- Willing to stop taking folate or folic acid supplements 48 hours before receiving CYTALUX.
- Agree to provide written consent to participate in the study.
Exclusion Criteria
- Any medical condition that could make participation unsafe.
- History of severe allergic reactions to similar imaging products.
- Allergy to any ingredients in CYTALUX.
- Any condition that could make it difficult to follow the study procedures or attend follow-up appointments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clemments University Hospital | 75235 | Dallas | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
