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New treatment option for Gastrointestinal Cancer
Official title Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
ClinicalTrials.gov ID: NCT07124351
What this study is testing
What is CYTALUX™ (pafolacianine)?
CYTALUX™ (pafolacianine) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastrointestinal cancer.
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
- This is an open-label study in adults to determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal).
- Phase 4: studies an already-approved treatment
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
- Patients 18 years of age and older of any sex.
- Have a primary diagnosis, or a high clinical suspicion, of gastroesophageal adenocarcinoma based on CT (computed tomography)/PET (positron emission...
- Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal disease...
- Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX.
- Willingness of research participant 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. people with a medical history of 'idiopathic...
- 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...
- Known sensitivity to fluorescent light.
- Women of childbearing potential who are pregnant or plan to become pregnant during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, 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 - 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?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.