Esophageal Cancer study: CYTALUX™
Official title Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.
ClinicalTrials.gov ID: NCT07039526
What this study is testing
What is CYTALUX™ (pafolacianine) injection?
This is an investigational injectable medicine being studied to help doctors see cancer during surgery for esophageal cancer. It is designed to attach to cancer cells and glow when viewed with a special camera.
Also referred to as pafolacianine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if CYTALUX (pafolacianine) can make cancer cells light up so surgeons can find them better during surgery.
- Who it's for
- Adults with suspected gastrointestinal, esophageal, pancreatic, hepatobiliary, or gynecologic cancers who are scheduled for surgery.
- What's involved
- Participants receive a single injection of the drug before surgery. During the operation, a special camera is used to look for the glowing cancer cells.
- Time commitment
- The study lasts about two months and involves the pre‑surgery injection and the surgical procedure with imaging.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and Female patients 18 years of age and older
- Have a primary diagnosis, or a high clinical suspicion, of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn...
- Are scheduled to undergo surgical intervention for tumor resection or diagnostic laparoscopy for assessment of disease burden.
- Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux
- Willingness of research participant or legal guardian/representative to give written informed consent.
You likely can't join if
- Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to products containing indocyanine green for near infrared imaging.
- History of allergy to any of the components of CYTALUX™ (pafolacianine) injection
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol...
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.